Continuation of Serplulimab Plus Chemotherapy After First Progression in Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma: an Open-label, Randomised Phase II Trial

NCT05942573 | Unknown Phase 2

• 1 other identifier: SCAFIGC
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)

Outcome Measures

Primary Outcomes (1)

• 6-month PFS%

  Progression-free survival by IRRC assessment per RECIST 1.1

  The Percent of patinets after first progression until disease progression in 6 months

Secondary Outcomes (3)

• OS

  From the date of first dose unitl the date of death from any cause，assessed up to 2 years ]

• PFS2

  From date of randomization until the date of second-line treatment progression or date of death from any cause, whichever came first

• PFS1

  From date of randomization until the date of first documented progressionor date of death from any cause, whichever came first

Study Arms (1)

continuation of Serplulimab plus chemotherapy after first progression

EXPERIMENTAL

Serplulimab+Paclitaxel+Apatinib Paclitaxel±Ramucirumab

Drug: Serplulimab+Paclitaxel+Apatinib; Drug: Paclitaxel±Ramucirumab

Interventions

Serplulimab+Paclitaxel+Apatinib DRUG

Immunotherapy+chemotherapy

Also known as: A:Drug:Serplulimab+paclitaxel+Apatinib

continuation of Serplulimab plus chemotherapy after first progression

Paclitaxel±Ramucirumab DRUG

chemotherapy±Targeted therapy

Also known as: B:Drug:paclitaxel±Ramucirumab

continuation of Serplulimab plus chemotherapy after first progression

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Serplulimab

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: July 12, 2023
• Study Start: December 24, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2024
• Last Updated: July 12, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)