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

Last updated: July 5, 2023
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Adenocarcinoma

Treatment

Paclitaxel±Ramucirumab

Serplulimab+Paclitaxel+Apatinib

Clinical Study ID

NCT05942573
SCAFIGC
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Volunteer to participate in this clinical study; completely understand and know thisstudy as well as sign the informed consent form (ICF); be willing to follow and beable 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 gastroesophagealjunction 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

Exclusion Criteria:

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

Study Design

Total Participants: 107
Treatment Group(s): 2
Primary Treatment: Paclitaxel±Ramucirumab
Phase: 2
Study Start date:
December 24, 2022
Estimated Completion Date:
December 31, 2024

Study 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

Connect with a study center

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

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