A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    690
  • sponsor
    Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Updated on 7 October 2022

Summary

This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study,the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.

Details
Condition Gastric or Gastroesophageal Junction Cancer
Treatment SHR-1701、CAPOX/FOLFOX, Placebo、CAPOX/FOLFOX, SHR-1701、CAPOX, Placebo、CAPOX
Clinical Study IdentifierNCT04950322
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ)adenocarcinoma
HER2 overexpression or amplification negative
Female or male, 18 years of age or above
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
Patients who are willing and able to provide the signed informed consent form, willing and able to comply with all the scheduled visits, study treatment, laboratory tests, and other study procedures

Exclusion Criteria

Squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer
Presence of inadequately treated CNS metastases, or uncontrolled or symptomatic active CNS metastases ,leptomeningeal disease, and/or rapid progression
Presence of uncontrolled pleural effusion or ascites despite puncture drainage within 14 days prior to randomization
More than 20% weight loss within 2 months prior to randomization
Diagnosed with other malignant tumors within 5 years prior to enrollment
Presence of any active, known or suspected autoimmune disease
Prior treatment with TGF-β inhibitor, anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies
Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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