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

Sponsor

Tianjin Medical University Cancer Institute and Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05942573

Collaborator

(none)

107

Enrollment

Location

Arm

24.2

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)	Drug: Serplulimab+Paclitaxel+Apatinib Drug: Paclitaxel±Ramucirumab	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

107 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

SerplulimabSerplulimab

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 24, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: continuation of Serplulimab plus chemotherapy after first progression Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab	Drug: Serplulimab+Paclitaxel+Apatinib Immunotherapy+chemotherapy Other Names: A:Drug:Serplulimab+paclitaxel+Apatinib Drug: Paclitaxel±Ramucirumab chemotherapy±Targeted therapy Other Names: B:Drug:paclitaxel±Ramucirumab

Arm

Intervention/Treatment

Experimental: continuation of Serplulimab plus chemotherapy after first progression

Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab

Drug: Serplulimab+Paclitaxel+Apatinib

Immunotherapy+chemotherapy

Other Names:

A:Drug:Serplulimab+paclitaxel+Apatinib

Drug: Paclitaxel±Ramucirumab

chemotherapy±Targeted therapy

Other Names:

B:Drug:paclitaxel±Ramucirumab

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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;
Age ≥ 18 years and ≤ 75 years when ICF is signed;
Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
never received systemic anti-tumor drug therapy before；
HER2 negative and PD-L1 CPS≥5;
Measurable lesion according to RECIST v1.1 by IRRC;
ECOG score 0-1;

Exclusion Criteria:

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