Tribute to the Chinese voice! The Apatini III AHELP study appeared in ASCO's oral report, "China Smart Manufacturing" handed over a bright-eyed business card.

The AHELP study is a forward-looking, randomized, double-blind, placebo-controlled Phase III registered clinical study of Apatinib II or above for the treatment of advanced hepatocellular carcinoma (HCC), led by Professor Qin Shuxuan and conducted by 31 cancer centers nationwide.
it is learned that the 2020 ASCO from the global field of liver cancer oral report only 3 seats, Apatini AHELP research exclusive 1 seat, which is a great encouragement to China's original, but also a great honor of China's intellectual creation.
This is a decade, independent research and development by national pharmaceutical companies, and led by Chinese scholars in innovative drug treatment late HCC large-scale clinical research success, was invited to the ASCO Conference to announce the results and data to the world, not only fully affirmed the effectiveness and safety of Apatinist, a targeted innovative drug treatment HCC, but also china's national pharmaceutical enterprises based on local research and development of innovative drugs, but also china's clinicians independent design, high-quality implementation, completion of large-scale critical clinical trial capacity and level of recognition.
background, the China Medical Tribune had the privilege of inviting Professor Li Qiu, who was sharing the fruits of Apatini's second-line treatment of advanced hepatocellular carcinoma, to be interviewed on behalf of the collaboration group for an online oral presentation.
AHELP research to the top of ASCO made the world see "China's intellectual creation" Professor Li Qiu first said, as a clinician, it is a great honor to be able to represent the Chinese oncology clinical community at the annual meeting of ASCO to make a voice that belongs to us in China.
pointed out that the AHELP study was included in the ASCO oral report for three main reasons.
first, globally, the incidence and mortality of liver cancer is still at a high level, but the treatment of liver cancer system drugs is relatively limited, patients have a shorter survival time, the global liver cancer field doctors face great challenges.
, China is a major country with about half of all new cases and deaths each year.
and China's liver cancer has a high degree of heterogeneity, most of china's liver cancer patients later in stages, combined hepatitis B virus infection, higher levels of fetal protein, so that patients have a worse prognosis.
based on the clinical research data of liver cancer patients in China, it is very important for the diagnosis and treatment of liver cancer in China and the world.
Third, the quality of AHELP research is reliable, although the baseline characteristics of the group of people compared to other areas of the study is worse, but through rigorous design, close cooperation, strict quality control, but ultimately obtained similar to the European and American studies or even can be said to be better positive results.
these three reasons, AHELP research can land on the world's top academic stage, so that the world see "China's intellectual creation."
AHELP study patient baseline characteristics are significantly worse, the therapeutic effect is no less than the AHELP study is led by Professor Qin Shuxuan, 31 cancer centers nationwide jointly conducted a forward-looking, randomized, double-blind, placebo-controlled phase III registered clinical study of Apatinib second-line or above treatment of advanced hepatocellular carcinoma (HCC).
included 393 patients with advanced HCC who had failed or were insulated after receiving at least one-line systemic treatment in the past, and were randomly assigned to the Apatini trial group (750 mg, 1/day) and the placebo control group (simulated tablets, 1/day) at 2:1.
Past systematic treatments include targeted therapy and/or system chemotherapy, requiring uniform entry criteria, including Child-Pugh liver function rating of A or B (≤7 points), BCLC station B or C, ECOG PS score 0-1, and at least one measurable lesions (based on RECIST 1.1).
Professor Li Qiu said that the baseline characteristics of patients are as follows: (1) the patients in the group are younger, the middle age of the apatini group is 51.4 years old, the middle age of the placebo group is 50.3 years old; About 90% of patients were phased out in Barcelona Phase C, (3) the patient's condition was more complex, the proportion of hepatitis B virus (HBV)-positive patients was more than 80%, AFP level ≥400 mg/L patients were over 50%, and 22.6% of patients received second- and third-line treatment.
above characteristics reflect the characteristics of chinese liver cancer patients.
Figure 1: AHELP study of patient baseline characteristics and past treatment Although the baseline of patients in the study group is worse, it is exciting that the AHELP study has achieved no less positive results than other second-line treatment late HCC studies such as RESORCE.
the main observational endpoint of the AHELP study was total lifetime (OS), with the apatinist group reaching 8.7 months, a significant increase over the placebo group's 6.8 months (Figure 2).
6-month OS rate and 12-month OS rate were 70% and 36.8%, respectively, significantly higher than the control group's 56.1% and 28.9%.
Figure 2: AHELP studied the total survival time of the Apatini and placebo groups in the secondary endpoint, and the Apatini group also showed a clear advantage, with a medium progression-free lifetime (PFS) of 4.5 months, higher than the placebo group of 1.9 months (Figure 3).
the objective remission rate (ORR) was 10.7 percent and 1.5 percent, respectively, and the disease control rate (DCR) was 61.3 percent and 28.8 percent, respectively.
safety, the safety of apatinib is controllable, treatment-related adverse events are consistent with previous clinical studies, and similar to other VEGFR-TKI drugs, no new adverse events have been observed.
Figure 3: AHELP study of non-progressive survival in the Apatini and placebo groups In another RESORCE study of the second-line treatment of advanced liver cancer, patients in the group were resistant to sorapinib and showed progression Only 38 percent of patients were HBV-positive; physical condition was better, with 65 percent of patients with ECOG PS scores 0, compared with 75.1 percent of patients with ECOG PS scores in the AHELP study and a worse baseline (Figure 4).
Figure 4: Compared with the standard second-line treatment plan, the baseline characteristics of the AHELP study group are closer to the clinical practice of liver cancer in China, but although the baseline situation of the patients in the group is not as good as the RESORCE study, the results of the AHELP study are not inferior to the former.
short-term efficacy, Apatini and Rigoffinist mPFS were 4.5 months and 3.4 months, respectively, and ORR was 10.7% and 7%, respectively.
comparing the AHLEP study with the RESORCE study of China subgroup data, in the case of similar baseline characteristics, the Rigoffini China subgroup ORR was 4% and mPFS was 2.8 months; The ORR and mPFS studied by AHELP were 10.7% and 4.6 months, respectively, again suggesting that Apatinist's second-line treatment of advanced HCC may have some advantages.
, in terms of long-term efficacy indicators, the main endpoint of the Apatini group in the AHELP study, mOS, was 8.7 months, with significant survival benefits compared to the placebo group.
reSORCE study in China showed that the mOS in the Rigoffini and placebo groups were 7.9 months and 4.9 months, respectively (HR=0.65, P=0.023).
In addition, the AHELP study sensitivity analysis assessed the effects of follow-up anti-tumor therapy on OS in two groups of patients, and the results showed that when reviewed at the beginning of follow-up anti-tumor therapy, Apatini and placebo mOS were 9.2 months and 6.3 months, respectively (HR=0.606, P=0.0010).
(Note: AHELP research and RESORCE research non-head-to-head comparison) In summary, Apatini with China's original research, China's original hard-core strength has achieved no less than the international large-scale clinical research, foreign original research products, which in the original exploration of the road to climb the Chinese scholars is also a great return and encouragement.
close cooperation and joint efforts with patients to explore a new second-line treatment of liver cancer AHELP research started, liver cancer has no standard second-line treatment plan, many patients face the situation of no cure.
this background, Professor Qin Shuxuan led Chinese scholars to carry out the national multi-center Phase III clinical trial of Apatinist II or above for the treatment of late HCC, which is of great clinical significance.
" Sichuan University Huaxi Hospital in a total of more than 30 patients, a middle-age male patient impressed me, this case after the progress of Solafini treatment, there is a wide range of lung metastasis, but fortunately the patient after a lot of screening was included in the AHELP study.
Professor Li Qiu shared, "After this patient entered the group, we actively treated adverse reactions, encouraged him to receive follow-up treatment, and finally in the joint efforts of patients and doctors, achieved a more satisfactory results, patient survival time of nearly two years."
the whole research process, the lead researcher, Professor Qin Shuxuan, led the research team of several centers to work closely together, and Professor Li Qiu said he had benefited a lot from it.
the future, we look forward to more opportunities to work together on more patient-friendly clinical research and to showcase our china's good voice on the international stage.
In a broader population, exploring more possibilities for Apatini in the treatment of liver cancer Professor Li Qiu also said that the success of clinical research on the treatment of advanced liver cancer on the second line or above of Apatini, in addition to its own scientific significance, has a clearer clinical significance for clinicians and patients of liver cancer in China, and has far-reaching implications for the development of the field of liver cancer in China.
the results give Chinese liver cancer patients more choices after rrigoffini, and more representative of the baseline characteristics of Chinese liver cancer patients.
expects that Apatinistinist will be approved as an early second-line treatment for advanced liver cancer, allowing researchers to explore the effectiveness and safety of apatinist in liver cancer treatment in a broader population.
the future, it is believed that apatinist immunotherapy will have more attempts in the field of liver cancer treatment.
international multi-center Phase III clinical trial of the Karelliju monoantigen-combined apatinist treatment for late HCC may give us more hope and inspiration.
Finally, it is worth noting that apatinib, as a new generation of small molecule vascular enditer growth factor-2 (VEGFR-2) tyrosine kinase inhibitor, is a broad-spectrum anti-tumor targeted drug, which has been used in gastric cancer treatment in the early stages With good results and approval for advanced gastric adenocarcinoma or gastric-esophageal combined adenocarcinoma, which has under been progressed or relapsed in at least two systems in the past, it is believed that more active exploration and attempts can be made in the future in the treatment of tumors other than liver and stomach cancer for the benefit of more patients.
As Professor Li Qiu said, the Phase III study of Apatini's second-line treatment of late HCC can be reported orally in ASCO, fully affirming the effectiveness and safety of Apatinist's treatment of HCC, and at the same time proving to the world the potential and future of drug research and clinical research in China.
to the west for decades, and now rise to create the future! It is expected that Apatini can be approved as soon as possible the second-line treatment of advanced liver cancer, so that researchers can explore the possibility of apatini in liver cancer treatment in a wider population, for China's liver cancer patients to create more miracles! References: 1. 2020 ASCO Abstract NO: 4507 2. Han GH, Qin SK, Song TQ, et al. Efficacy and safety of regorafenib (REG) versus placebo (PBO) in Chinese patients with hepatocellular carcinoma (HCC) progressing on sorafenib (SOR): subgroup analysis of the international, randomized phase 3 RESORCE trial. PL015. APASL2017, Shanghai, Feb 15-19, 2017. 3. Bruix J, Qin S, Merle P, Granito A, Huang Y, Bodoky GR, Pracht M, Yokosuka O, Rosmorduc O, Breder V (Regorafenib for patients with hepatocell carcinoma whos progressed on sorafenib (RESORCE): a randomed, double-blind, LANCET 389: 56-66.