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Trial Title:
Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
NCT ID:
NCT05942573
Condition:
Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
Conditions: Official terms:
Adenocarcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Apatinib
Ramucirumab
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Serplulimab
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab+Paclitaxel+Apatinib
Description:
Immunotherapy+chemotherapy
Arm group label:
continuation of Serplulimab plus chemotherapy after first progression
Other name:
A:Drug:Serplulimab+paclitaxel+Apatinib
Intervention type:
Drug
Intervention name:
Paclitaxel±Ramucirumab
Description:
chemotherapy±Targeted therapy
Arm group label:
continuation of Serplulimab plus chemotherapy after first progression
Other name:
B:Drug:paclitaxel±Ramucirumab
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Bai, MD
Phone:
+8613820741351
Email:
bmmhead1982@126.com
Contact backup:
Last name:
Ting Deng, MD
Start date:
December 24, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05942573
