Back to resultsContinuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
Primary Purpose
Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Serplulimab+Paclitaxel+Apatinib
Paclitaxel±Ramucirumab
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
Eligibility Criteria
Inclusion Criteria: 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; Age ≥ 18 years and ≤ 75 years when ICF is signed; Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma; never received systemic anti-tumor drug therapy before； HER2 negative and PD-L1 CPS≥5; Measurable lesion according to RECIST v1.1 by IRRC; ECOG score 0-1; Exclusion Criteria: Has other active malignancies within 5 years before the first administration of the study drug; Plan to or have previously received organ or bone marrow transplantation; Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; Have received any research drugs within 14 days before the first use of the study drugs.
Sites / Locations
- Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
continuation of Serplulimab plus chemotherapy after first progression
Arm Description
Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab
Outcomes
Primary Outcome Measures
6-month PFS%
Progression-free survival by IRRC assessment per RECIST 1.1
Secondary Outcome Measures
OS
Overall survival
PFS2
Progression-free survival by IRRC assessment per RECIST 1.1
PFS1
Progression-free survival by IRRC assessment per RECIST 1.1
Full Information
NCT ID
NCT05942573
First Posted
April 17, 2023
Last Updated
July 5, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05942573
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Serplulimab
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
continuation of Serplulimab plus chemotherapy after first progression
Arm Type
Experimental
Arm Description
Serplulimab+Paclitaxel+Apatinib
Paclitaxel±Ramucirumab
Intervention Type
Drug
Intervention Name(s)
Serplulimab+Paclitaxel+Apatinib
Other Intervention Name(s)
A:Drug:Serplulimab+paclitaxel+Apatinib
Intervention Description
Immunotherapy+chemotherapy
Intervention Type
Drug
Intervention Name(s)
Paclitaxel±Ramucirumab
Other Intervention Name(s)
B:Drug:paclitaxel±Ramucirumab
Intervention Description
chemotherapy±Targeted therapy
Primary Outcome Measure Information:
Title
6-month PFS%
Description
Progression-free survival by IRRC assessment per RECIST 1.1
Time Frame
The Percent of patinets after first progression until disease progression in 6 months
Secondary Outcome Measure Information:
Title
OS
Description
Overall survival
Time Frame
From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]
Title
PFS2
Description
Progression-free survival by IRRC assessment per RECIST 1.1
Time Frame
From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first
Title
PFS1
Description
Progression-free survival by IRRC assessment per RECIST 1.1
Time Frame
From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Age ≥ 18 years and ≤ 75 years when ICF is signed;
Unresectable locally advanced, or metastatic gastric cancer including gastroesophageal junction cancer, and histopathologically confirmed diagnosis of adenocarcinoma;
never received systemic anti-tumor drug therapy before；
HER2 negative and PD-L1 CPS≥5;
Measurable lesion according to RECIST v1.1 by IRRC;
ECOG score 0-1;
Exclusion Criteria:
Has other active malignancies within 5 years before the first administration of the study drug;
Plan to or have previously received organ or bone marrow transplantation;
Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
Have received any research drugs within 14 days before the first use of the study drugs.
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Bai, MD
Phone
+8613820741351
Email
bmmhead1982@126.com
First Name & Middle Initial & Last Name & Degree
Ting Deng, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial
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