Clinical trial NCT05942573: Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Serplulimab
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: 6-month PFS%
timeFrame: The Percent of patinets after first progression until disease progression in 6 months
Secondary outcomes:
measure: OS
timeFrame: From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]
measure: PFS2
timeFrame: From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first
measure: PFS1
timeFrame: From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: