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Editor’s note iNature is China’s largest academic official account.
It is jointly created by the doctoral team of Tsinghua University, Harvard University, Chinese Academy of Sciences and other units.
The iNature Talent Official Account is now launched, focusing on talent recruitment, academic progress, scientific research information, interested parties can Long press or scan the QR code below to follow us
.
iNature In 2018, esophageal cancer was the seventh most common cancer in the global population and the sixth most common cause of cancer-related death
.
The standard first-line treatment for advanced or metastatic esophageal cancer is chemotherapy, but the prognosis is still poor
.
Camrelizumab (Karelizumab, Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
, an anti-programmed death receptor 1 [PD-1] antibody) has shown resistance to previously treated advanced or metastatic esophageal squamous cell carcinoma Tumor activity
.
On September 14, 2021, Xu Ruihua of Sun Yat-sen University and other teams published online in the top international medical journal JAMA entitled "Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma, The ESCORT-1st Randomized Clinical Trial" research paper, this randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (ESCORT-1st study) was recruited from December 3, 2018 to May 12, 2020 Patients from 60 hospitals in China (final follow-up October 30, 2020)
.
A total of 751 patients were screened and 596 eligible untreated patients with advanced or metastatic esophageal squamous cell carcinoma were randomized
.
Patients were randomly assigned 1:1 to receive camrelizumab 200 mg (n = 298) or placebo (n = 298), combined with paclitaxel (175 mg/m2) and cisplatin (75 mg/m2) for up to 6 cycles
.
All treatments were administered intravenously every 3 weeks
.
The primary endpoints are overall survival and progression-free survival
.
Among 596 patients randomly assigned (median age, 62 years [interquartile range, 56-67 years]; 523 men [87.
8%]), 1 patient in the placebo-chemotherapy group did not receive the planned treatment
.
A total of 490 patients (82.
2%) discontinued study treatment
.
The median follow-up time was 10.
8 months
.
The median survival of the camrelizumab chemotherapy group was 15.
3 months (95% CI, 12.
8-17.
3; 135 deaths), while the median survival of the placebo chemotherapy group was 12.
0 months (95% CI, 11.
0-13.
3; 174 Death) (hazard ratio of death [HR], 0.
70 [95% CI, 0.
56-0.
88]; one-sided P = .
001)
.
The progression-free survival of camrelizumab plus chemotherapy was 6.
9 months (95% CI, 5.
8-7.
4; 199 cases of progression or death), while placebo-chemotherapy was 5.
6 months (95% CI, 5.
5-5.
7; 229 cases of progression or Death) (HR for progression or death, 0.
56 [95% CI, 0.
46-0.
68]; one-sided P <.
001)
.
189 patients (63.
4%) in the carrelizumab chemotherapy group and 201 patients (67.
7%) in the placebo chemotherapy group had treatment-related adverse events of grade 3 or higher, including 9 patients (3.
0%) and 11 patients, respectively There were treatment-related deaths in 3 patients (3.
7%)
.
In conclusion, in patients with advanced or metastatic esophageal squamous cell carcinoma, compared with placebo and chemotherapy, adding carrelizumab to chemotherapy can significantly improve overall survival and progression-free survival
.
In addition, on September 6, 2021, Ruihua Xu and Feng Wang of Sun Yat-sen University jointly published a research paper entitled "Genomic temporal heterogeneity of circulating tumour DNA in unresectable metastatic colorectal cancer under first-line treatment" in Gut (IF=23.
06).
This prospective, continuous, and large-scale ctDNA analysis study revealed the temporal heterogeneity of mCRC-related somatic mutations.
Special attention should be paid to this point in clinical practice.
This finding proves that changes in plasma RAS/BRAF mutation status can produce The drastic change in survival results (click to read)
.
On August 2, 2021, Ruihua Xu’s team from Sun Yat-sen University published a research paper titled "Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial" in Nature Medicine online, which is comparable to a separate GP.
Compared with the addition of teriprizumab to GP chemotherapy as the first-line treatment for patients with RM-NPC, it provides better PFS and has controllable safety (click to read)
.
On March 1, 2021, Ruihua Xu’s team from Sun Yat-Sen University published an online publication titled “Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial ( POLARIS-02)" research paper.
This study is a single-arm, multi-center phase II study.
RM-NPC patients receive an intravenous infusion of 3 mg/kg teriprizumab every 2 weeks until the disease progression is confirmed or Unacceptable toxicity occurs
.
The primary endpoint is the objective response rate (ORR)
.
This study demonstrated the controllable safety and long-lasting clinical response of teriprizumab in chemotherapy-refractory metastatic NPC patients
.
An early reduction in the copy number of plasma EBV DNA is associated with a favorable response (click to read)
.
On May 17, 2021, Professor Xu Ruihua and Professor Wang Feng from the Cancer Center of Sun Yat-sen University, Professor Cai Sanjun from Fudan University Cancer Hospital and Professor Ding Kefeng from the Second Affiliated Hospital of Zhejiang University School of Medicine were online in the Journal of Hematology & Oncology (IF=11.
06) Published a research paper entitled "Postoperativecirculating tumor DNA as markers of recurrence risk in stages II to IIIcolorectal cancer", the multicenter team carried out a prospective, observational cohort study to explore the early prediction of blood circulating tumor DNA (ctDNA) The role of mid-stage colorectal cancer in the risk of recurrence after radical resection
.
The study found that in early and mid-stage colorectal cancer patients, postoperative ctDNA-positive patients have a significantly higher risk of recurrence than ctDNA-negative patients, and that dynamic ctDNA detection can predict tumor recurrence an average of 5.
01 months earlier than conventional imaging methods such as CT scans
.
ctDNA detection is expected to be used to guide accurate decision-making and follow-up monitoring of adjuvant treatment after surgery (click to read)
.
In 2018, esophageal cancer was the seventh most common cancer in the global population and the sixth most common cause of cancer-related death
.
The histological subtype of esophageal cancer varies from region to region.
Esophageal squamous cell carcinoma (ESCC) is the main subtype in Asia, and esophageal adenocarcinoma is the main subtype in Australia, the United States and some Western European countries
.
Patients with esophageal cancer usually have advanced disease or metastasis at the time of diagnosis.
The current recommended standard is that the first-line treatment for this advanced or metastatic disease is chemotherapy
.
However, based on data from several prospective clinical studies, the overall survival of patients receiving standard treatment and two cytotoxic drugs is still limited, with a median of 7.
0 to 13.
0 months
.
Therefore, new drugs and strategies are needed to improve clinical outcomes
.
Inhibition of Programmed Death Receptor 1 (PD-1) and its ligand (PD-L1) have been effective in treating a variety of cancers
.
Camrelizumab (Carrelizumab, Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
), a humanized, selective PD-1 IgG4-κ monoclonal antibody, exerts anti-tumor activity in a variety of tumors
.
In the randomized phase 3 ESCORT study, compared with chemotherapy, camrelizumab significantly improved the overall survival and remission rate of patients with advanced or metastatic ESCC as a second-line treatment, which led to its approval by the China National Medical Products Administration as a treatment for this population.
Second-line treatment
.
The combination of immunotherapy and cytotoxic drugs has shown encouraging anti-tumor activity in a variety of tumor types, but there is a lack of data to support this approach as a first-line treatment strategy for advanced ESCC
.
In this context, this randomized, double-blind, placebo-controlled, multi-center phase 3 trial (ESCORT-1st study) was conducted to evaluate carrelizumab plus chemotherapy compared with placebo plus chemotherapy.
Efficacy and adverse events of treated advanced ESCC
.
This randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (ESCORT-1st study) recruited patients from 60 hospitals in China between December 3, 2018 and May 12, 2020 (final follow-up October 30, 2020)
.
A total of 751 patients were screened and 596 eligible untreated patients with advanced or metastatic esophageal squamous cell carcinoma were randomized
.
Patients were randomly assigned 1:1 to receive camrelizumab 200 mg (n = 298) or placebo (n = 298), combined with paclitaxel (175 mg/m2) and cisplatin (75 mg/m2) for up to 6 cycles
.
All treatments were administered intravenously every 3 weeks
.
The primary endpoints are overall survival and progression-free survival
.
Among 596 patients randomly assigned (median age, 62 years [interquartile range, 56-67 years]; 523 men [87.
8%]), 1 patient in the placebo-chemotherapy group did not receive the planned treatment
.
A total of 490 patients (82.
2%) discontinued the study treatment
.
The median follow-up time was 10.
8 months
.
The median survival of the camrelizumab chemotherapy group was 15.
3 months (95% CI, 12.
8-17.
3; 135 deaths), while the median survival of the placebo chemotherapy group was 12.
0 months (95% CI, 11.
0-13.
3; 174 Death) (hazard ratio of death [HR], 0.
70 [95% CI, 0.
56-0.
88]; one-sided P = .
001)
.
The progression-free survival of camrelizumab plus chemotherapy was 6.
9 months (95% CI, 5.
8-7.
4; 199 cases of progression or death), while placebo-chemotherapy was 5.
6 months (95% CI, 5.
5-5.
7; 229 cases of progression or Death) (HR for progression or death, 0.
56 [95% CI, 0.
46-0.
68]; one-sided P <.
001)
.
189 patients (63.
4%) in the carrelizumab chemotherapy group and 201 patients (67.
7%) in the placebo chemotherapy group had treatment-related adverse events of grade 3 or higher, including 9 patients (3.
0%) and 11 patients, respectively There were treatment-related deaths in 3 patients (3.
7%)
.
In conclusion, in patients with advanced or metastatic esophageal squamous cell carcinoma, compared with placebo and chemotherapy, adding carrelizumab to chemotherapy can significantly improve overall survival and progression-free survival
.
Reference message: https://jamanetwork.
com/journals/jama/article-abstract/2784143
It is jointly created by the doctoral team of Tsinghua University, Harvard University, Chinese Academy of Sciences and other units.
The iNature Talent Official Account is now launched, focusing on talent recruitment, academic progress, scientific research information, interested parties can Long press or scan the QR code below to follow us
.
iNature In 2018, esophageal cancer was the seventh most common cancer in the global population and the sixth most common cause of cancer-related death
.
The standard first-line treatment for advanced or metastatic esophageal cancer is chemotherapy, but the prognosis is still poor
.
Camrelizumab (Karelizumab, Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
, an anti-programmed death receptor 1 [PD-1] antibody) has shown resistance to previously treated advanced or metastatic esophageal squamous cell carcinoma Tumor activity
.
On September 14, 2021, Xu Ruihua of Sun Yat-sen University and other teams published online in the top international medical journal JAMA entitled "Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma, The ESCORT-1st Randomized Clinical Trial" research paper, this randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (ESCORT-1st study) was recruited from December 3, 2018 to May 12, 2020 Patients from 60 hospitals in China (final follow-up October 30, 2020)
.
A total of 751 patients were screened and 596 eligible untreated patients with advanced or metastatic esophageal squamous cell carcinoma were randomized
.
Patients were randomly assigned 1:1 to receive camrelizumab 200 mg (n = 298) or placebo (n = 298), combined with paclitaxel (175 mg/m2) and cisplatin (75 mg/m2) for up to 6 cycles
.
All treatments were administered intravenously every 3 weeks
.
The primary endpoints are overall survival and progression-free survival
.
Among 596 patients randomly assigned (median age, 62 years [interquartile range, 56-67 years]; 523 men [87.
8%]), 1 patient in the placebo-chemotherapy group did not receive the planned treatment
.
A total of 490 patients (82.
2%) discontinued study treatment
.
The median follow-up time was 10.
8 months
.
The median survival of the camrelizumab chemotherapy group was 15.
3 months (95% CI, 12.
8-17.
3; 135 deaths), while the median survival of the placebo chemotherapy group was 12.
0 months (95% CI, 11.
0-13.
3; 174 Death) (hazard ratio of death [HR], 0.
70 [95% CI, 0.
56-0.
88]; one-sided P = .
001)
.
The progression-free survival of camrelizumab plus chemotherapy was 6.
9 months (95% CI, 5.
8-7.
4; 199 cases of progression or death), while placebo-chemotherapy was 5.
6 months (95% CI, 5.
5-5.
7; 229 cases of progression or Death) (HR for progression or death, 0.
56 [95% CI, 0.
46-0.
68]; one-sided P <.
001)
.
189 patients (63.
4%) in the carrelizumab chemotherapy group and 201 patients (67.
7%) in the placebo chemotherapy group had treatment-related adverse events of grade 3 or higher, including 9 patients (3.
0%) and 11 patients, respectively There were treatment-related deaths in 3 patients (3.
7%)
.
In conclusion, in patients with advanced or metastatic esophageal squamous cell carcinoma, compared with placebo and chemotherapy, adding carrelizumab to chemotherapy can significantly improve overall survival and progression-free survival
.
In addition, on September 6, 2021, Ruihua Xu and Feng Wang of Sun Yat-sen University jointly published a research paper entitled "Genomic temporal heterogeneity of circulating tumour DNA in unresectable metastatic colorectal cancer under first-line treatment" in Gut (IF=23.
06).
This prospective, continuous, and large-scale ctDNA analysis study revealed the temporal heterogeneity of mCRC-related somatic mutations.
Special attention should be paid to this point in clinical practice.
This finding proves that changes in plasma RAS/BRAF mutation status can produce The drastic change in survival results (click to read)
.
On August 2, 2021, Ruihua Xu’s team from Sun Yat-sen University published a research paper titled "Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial" in Nature Medicine online, which is comparable to a separate GP.
Compared with the addition of teriprizumab to GP chemotherapy as the first-line treatment for patients with RM-NPC, it provides better PFS and has controllable safety (click to read)
.
On March 1, 2021, Ruihua Xu’s team from Sun Yat-Sen University published an online publication titled “Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial ( POLARIS-02)" research paper.
This study is a single-arm, multi-center phase II study.
RM-NPC patients receive an intravenous infusion of 3 mg/kg teriprizumab every 2 weeks until the disease progression is confirmed or Unacceptable toxicity occurs
.
The primary endpoint is the objective response rate (ORR)
.
This study demonstrated the controllable safety and long-lasting clinical response of teriprizumab in chemotherapy-refractory metastatic NPC patients
.
An early reduction in the copy number of plasma EBV DNA is associated with a favorable response (click to read)
.
On May 17, 2021, Professor Xu Ruihua and Professor Wang Feng from the Cancer Center of Sun Yat-sen University, Professor Cai Sanjun from Fudan University Cancer Hospital and Professor Ding Kefeng from the Second Affiliated Hospital of Zhejiang University School of Medicine were online in the Journal of Hematology & Oncology (IF=11.
06) Published a research paper entitled "Postoperativecirculating tumor DNA as markers of recurrence risk in stages II to IIIcolorectal cancer", the multicenter team carried out a prospective, observational cohort study to explore the early prediction of blood circulating tumor DNA (ctDNA) The role of mid-stage colorectal cancer in the risk of recurrence after radical resection
.
The study found that in early and mid-stage colorectal cancer patients, postoperative ctDNA-positive patients have a significantly higher risk of recurrence than ctDNA-negative patients, and that dynamic ctDNA detection can predict tumor recurrence an average of 5.
01 months earlier than conventional imaging methods such as CT scans
.
ctDNA detection is expected to be used to guide accurate decision-making and follow-up monitoring of adjuvant treatment after surgery (click to read)
.
In 2018, esophageal cancer was the seventh most common cancer in the global population and the sixth most common cause of cancer-related death
.
The histological subtype of esophageal cancer varies from region to region.
Esophageal squamous cell carcinoma (ESCC) is the main subtype in Asia, and esophageal adenocarcinoma is the main subtype in Australia, the United States and some Western European countries
.
Patients with esophageal cancer usually have advanced disease or metastasis at the time of diagnosis.
The current recommended standard is that the first-line treatment for this advanced or metastatic disease is chemotherapy
.
However, based on data from several prospective clinical studies, the overall survival of patients receiving standard treatment and two cytotoxic drugs is still limited, with a median of 7.
0 to 13.
0 months
.
Therefore, new drugs and strategies are needed to improve clinical outcomes
.
Inhibition of Programmed Death Receptor 1 (PD-1) and its ligand (PD-L1) have been effective in treating a variety of cancers
.
Camrelizumab (Carrelizumab, Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
), a humanized, selective PD-1 IgG4-κ monoclonal antibody, exerts anti-tumor activity in a variety of tumors
.
In the randomized phase 3 ESCORT study, compared with chemotherapy, camrelizumab significantly improved the overall survival and remission rate of patients with advanced or metastatic ESCC as a second-line treatment, which led to its approval by the China National Medical Products Administration as a treatment for this population.
Second-line treatment
.
The combination of immunotherapy and cytotoxic drugs has shown encouraging anti-tumor activity in a variety of tumor types, but there is a lack of data to support this approach as a first-line treatment strategy for advanced ESCC
.
In this context, this randomized, double-blind, placebo-controlled, multi-center phase 3 trial (ESCORT-1st study) was conducted to evaluate carrelizumab plus chemotherapy compared with placebo plus chemotherapy.
Efficacy and adverse events of treated advanced ESCC
.
This randomized, double-blind, placebo-controlled, multicenter, phase 3 trial (ESCORT-1st study) recruited patients from 60 hospitals in China between December 3, 2018 and May 12, 2020 (final follow-up October 30, 2020)
.
A total of 751 patients were screened and 596 eligible untreated patients with advanced or metastatic esophageal squamous cell carcinoma were randomized
.
Patients were randomly assigned 1:1 to receive camrelizumab 200 mg (n = 298) or placebo (n = 298), combined with paclitaxel (175 mg/m2) and cisplatin (75 mg/m2) for up to 6 cycles
.
All treatments were administered intravenously every 3 weeks
.
The primary endpoints are overall survival and progression-free survival
.
Among 596 patients randomly assigned (median age, 62 years [interquartile range, 56-67 years]; 523 men [87.
8%]), 1 patient in the placebo-chemotherapy group did not receive the planned treatment
.
A total of 490 patients (82.
2%) discontinued the study treatment
.
The median follow-up time was 10.
8 months
.
The median survival of the camrelizumab chemotherapy group was 15.
3 months (95% CI, 12.
8-17.
3; 135 deaths), while the median survival of the placebo chemotherapy group was 12.
0 months (95% CI, 11.
0-13.
3; 174 Death) (hazard ratio of death [HR], 0.
70 [95% CI, 0.
56-0.
88]; one-sided P = .
001)
.
The progression-free survival of camrelizumab plus chemotherapy was 6.
9 months (95% CI, 5.
8-7.
4; 199 cases of progression or death), while placebo-chemotherapy was 5.
6 months (95% CI, 5.
5-5.
7; 229 cases of progression or Death) (HR for progression or death, 0.
56 [95% CI, 0.
46-0.
68]; one-sided P <.
001)
.
189 patients (63.
4%) in the carrelizumab chemotherapy group and 201 patients (67.
7%) in the placebo chemotherapy group had treatment-related adverse events of grade 3 or higher, including 9 patients (3.
0%) and 11 patients, respectively There were treatment-related deaths in 3 patients (3.
7%)
.
In conclusion, in patients with advanced or metastatic esophageal squamous cell carcinoma, compared with placebo and chemotherapy, adding carrelizumab to chemotherapy can significantly improve overall survival and progression-free survival
.
Reference message: https://jamanetwork.
com/journals/jama/article-abstract/2784143
