Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the Treatment of Advanced Gastric and Esophageal Cancer

April 1, 2024 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

A Randomized, Open, Multicenter Phase II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the First-line Treatment of Advanced Gastric and Esophageal Cancer

Objective response rate (ORR) was evaluated to evaluate the efficacy of SHR-8068 combined with adebrelimab and platinum-containing chemotherapy in first-line treatment of advanced gastric and esophageal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Principal Investigator:
          • Jianming Xu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
  2. Aged 18-75 at the time of signing the informed consent;
  3. Histologically or cytologically confirmed, unresectable, advanced or recurrent/metastatic adenocarcinoma of the gastric or gastroesophageal junction, or unresectable or recurrent/metastatic esophageal squamous cell carcinoma without radical chemoradiation;
  4. At least one measurable lesion consistent with RECIST v1.1;
  5. ECOG PS score: 0-1;
  6. The organ function level is good;

Exclusion Criteria:

  1. Her2-positive patients;
  2. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
  3. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
  4. Previous or co-existing malignant neoplasms;
  5. The presence of any active or known autoimmune disease;
  6. People who have previously received an organ transplant;
  7. Have clinical symptoms or diseases of the heart that are not well controlled;
  8. Known allergic reactions to adebrelimab or other monoclonal antibodies or investigational drugs;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-8068 combined with adebrelimab and platinum-containing chemotherapy
Drug: SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection
SHR-8068: Specified dose on specified days. Adebrelimab: Specified dose on specified days. Oxaliplatin: Specified dose on specified days. Capecitabine Tablets: Specified dose on specified days. Paclitaxel Injection: Specified dose on specified days. Cisplatin Injection: Specified dose on specified days.
Active Comparator: Adebrelimab combined with platinum-containing chemotherapy
Drug: Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection
Adebrelimab: Specified dose on specified days. Oxaliplatin Injection: Specified dose on specified days. Capecitabine Tablets: Specified dose on specified days. Paclitaxel Injection: Specified dose on specified days. Cisplatin Injection: Specified dose on specified days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ORR based on RECIST v1.1 assessment.
Time Frame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years

Secondary Outcome Measures

Outcome Measure
Time Frame
DCR based on RECIST v1.1 assessment
Time Frame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years
All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-8068-201-GC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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