Clinical trial · Interventional
Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
SCAFIGC：Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ) | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel±Ramucirumab | Drug | — | UNRESOLVED |
| Serplulimab+Paclitaxel+Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- continuation of Serplulimab plus chemotherapy after first progression
- description
- Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab
- interventionNames
- Drug: Serplulimab+Paclitaxel+Apatinib
- Drug: Paclitaxel±Ramucirumab
Primary outcomes (1)
- measure
- 6-month PFS%
- timeFrame
- The Percent of patinets after first progression until disease progression in 6 months
- description
- Progression-free survival by IRRC assessment per RECIST 1.1
Secondary outcomes (3)
- measure
- OS
- timeFrame
- From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available