NCT05942573

Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial

SCAFIGC：Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer(patients with HER2 negative and PD-L1 CPS≥5).Patiens will recevie Serplulimab plus chemotherapy ((oxaliplatin+capecitabine) as first-line treatment. After PD，patients will randomly 2：1 assigned to treatment：one group will receive Serpluimab with Paclitaxel,Apatinib；another group will receive Paclitaxel with or without Ramucirumab.All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent

Detailed description

stage one ：Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+oxaliplatin130mg/m2 iv.gtt d1+capecitabine 1000mg/m2 p.o.b.i.d d1\~d14,q3w stage two:Serplulimab 3mg/kg,d1,q2w or 4.5mg/kg,d1,q3w+Apatinib 250mg/qd+Paclitaxel 135\~175mg/m2 iv.gtt,d1,q3w Paclitaxel 135\~175mg/m2 iv.gtt,d1,q3w±Ramucirumab 8mg/kg,d1,q2w

Conditions

• Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)

Interventions

Type	Name	Description
DRUG	Serplulimab+Paclitaxel+Apatinib	Immunotherapy+chemotherapy
DRUG	Paclitaxel±Ramucirumab	chemotherapy±Targeted therapy

Timeline

• Start date: 2022-12-24
• Primary completion: 2023-10-01
• Completion: 2024-12-31
• First posted: 2023-07-12
• Last updated: 2023-07-12

Locations

1 site across 1 country: China