NCT04139135

A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer

A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 642 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the efficacy of HLX10 combined with chemotherapy versus placebo combined with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer. Subjects will be randomized to the following two arms at 1: 1 ratio: * Arm A (HLX10 arm): HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase; * Arm B (control arm): Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase. Chemotherapy regimen SOX (oxaliplatin + tegafor gimeracil oteracil potassium (S-1)) will be used in the neoadjuvant treatment phase in Arm A and B, and in the adjuvant treatment phase in Arm B. After randomization, subjects will receive a total of 3 cycles of neoadjuvant treatment with the mentioned treatment regimen.Surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant treatment.All subjects who have completed the surgery will be unblinded after surgery, and adjuvant treatment will be started 3 to 12 weeks after surgery. Subjects randomized to Arm A (HLX10 arm) will continue to receive HLX10 monotherapy for up to 17 cycles (12 months).Subjects in Arm B after surgery (control arm) will continue to use chemotherapy alone (oxaliplatin + S-1) for 5 cycles.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	HLX10	neoadjuvant treatment phase：HLX10（4.5mg/kg/3w IV） +SOX, adjuvant treatment phase：HLX10（4.5mg/kg/3w IV）
DRUG	Placebos	neoadjuvant treatment phase：placebos（4.5mg/kg/3w IV） +SOX, adjuvant treatment phase：SOX

Timeline

• Start date: 2019-12-12
• Primary completion: 2023-10-01
• Completion: 2024-10-01
• First posted: 2019-10-25
• Last updated: 2022-06-06

Locations

15 sites across 1 country: China