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

Phase 2

Recruiting

• Conditions: Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
• Interventions: Drug: Serplulimab+Paclitaxel+Apatinib; Drug: Paclitaxel±Ramucirumab

• Registration Number: NCT05942573
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-12-24
• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-05
• Study First Posted: 2023-07-12
• Last Update Posted: 2023-07-12
• Primary Completion: 2023-10
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
2. Age ≥ 18 years and ≤ 75 years when ICF is signed;
3. Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
4. never received systemic anti-tumor drug therapy before；
5. HER2 negative and PD-L1 CPS≥5;
6. Measurable lesion according to RECIST v1.1 by IRRC;
7. ECOG score 0-1;

Exclusion Criteria

1. Has other active malignancies within 5 years before the first administration of the study drug;
2. Plan to or have previously received organ or bone marrow transplantation;
3. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
4. Have received any research drugs within 14 days before the first use of the study drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
continuation of Serplulimab plus chemotherapy after first progression	Serplulimab+Paclitaxel+Apatinib	Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab
continuation of Serplulimab plus chemotherapy after first progression	Paclitaxel±Ramucirumab	Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab

Primary Outcome Measures

Name	Time	Method
6-month PFS%	The Percent of patinets after first progression until disease progression in 6 months	Progression-free survival by IRRC assessment per RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
PFS1	From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first	Progression-free survival by IRRC assessment per RECIST 1.1
OS	From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]	Overall survival
PFS2	From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first	Progression-free survival by IRRC assessment per RECIST 1.1

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China