Hengrui PD-1 combination therapy first-line treatment of nasopharyngeal cancer Phase III clinical reached the main endpoint.

The study (CAPTAIN-1st Study) was an evaluation of the effectiveness and safety of injection-based carelli-pearl monoantigen and gissythabhamin contrast placebo combined cisplatin and gissythabhamin for first-line treatment of local recurrence or metastatic nasopharyngeal cancer Randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies (CTR20181864, NCT03707509), led by Professor Zhang Zhang of Sun Yat-sen University-affiliated Oncology Hospital.
research endpoint of the study was progress-free survival (PFS) assessed by the Independent Review Board (IRC) on the basis of reCIST v1.1.
secondary study endpoints include PFS assessed by researchers, objective efficiency (ORR), total lifetime (OS), and safety.
The study included 250 subjects who were randomly assigned to a group of 1:1, who received a combined 4-6 cycles of injection with carellidot monoantigen or placebo combined cisplatin and gissythabhamin, followed by an injection of carellidate monoantigen or placebo to maintain treatment until the disease progressed, toxicity was not acceptable, or other conditions required termination of treatment.
Recently, the study by the Independent Data Monitoring Committee (IDMC) determined that the main study end of the period analysis results reached the program preset of the best efficiency standards, the results show that injection with kariliju monoantigen anti-combined cisplatin and gisithamin first-line treatment of local recurrence or distant metastatic nasopharyngeal cancer patients, compared to cisplatin gigisithadin standard first-line treatment, can significantly extend the survival of patients without progress.
announced that so far, the cumulative investment in research and development costs of the injection karili pearl monoantigen has been about 111,797 million yuan.
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