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
Study ID
NCT05942573
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Dec 24, 2022
Status verified
Oct 2022
Primary completion
Oct 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
107 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: continuation of Serplulimab plus chemotherapy after first progression
    Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab

Primary Outcome Measure

6-month PFS% [ Time Frame: The Percent of patinets after first progression until disease progression in 6 months ]