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NCT Number: NCT06247956

Study of SHR-8068 Combined With Adebrelimab and Platinum-containing Chemotherapy in the 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
  • Aged 18-75 at the time of signing the informed consent;
  • 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;
  • At least one measurable lesion consistent with RECIST v1.1;
  • ECOG PS score: 0-1;
  • The organ function level is good;

Exclusion criteria

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

Treatment and study plan

SHR-8068;Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection

Drug

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.

Adebrelimab;Oxaliplatin;Capecitabine Tablets;Paclitaxel Injection;Cisplatin Injection

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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