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

July 5, 2023 updated by: Tianjin Medical University Cancer Institute and Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

107

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
        • Contact:
          • Ting Deng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month PFS%
Time Frame: The Percent of patinets after first progression until disease progression in 6 months
Progression-free survival by IRRC assessment per RECIST 1.1
The Percent of patinets after first progression until disease progression in 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]
Overall survival
From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]
PFS2
Time Frame: 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
From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first
PFS1
Time Frame: 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
From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2022

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAFIGC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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