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NCT Number: NCT04950322

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric or Gastroesophageal Junction Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 1000000, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

SHR-1701、CAPOX

Drug

SHR-1701 with CAPOX (CAPOX:Oxaliplatin,Capecitabine)

Placebo、CAPOX

Drug

Placebo with CAPOX (CAPOX:Oxaliplatin,Capecitabine)

Primary outcomes

  1. AEs and SAEs in part 1 study

    Time frame: up to 2 years

    The number and proportion of subjects with dose limiting toxicity. The safety endpoints, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

  2. Overall survival in subjects with PD-L1 CPS ≥ 5 in part 2 study

    Time frame: up to 3 years

  3. OS in all subjects in part 2 study

    Time frame: up to 3 years

    Overall survival (OS)

Secondary outcomes

  1. ORR in part 1 study

    Time frame: up to 2 years

    Objective response rate (ORR) as assessed by the investigator per RECIST 1.1

  2. DCR in part 1 study

    Time frame: up to 2 years

    Disease control rate (DCR) as assessed by the investigator per RECIST 1.1

  3. PFS in part 1 study

    Time frame: up to 2 years

    Progression free survival (PFS) as assessed by the investigator per RECIST 1.1

  4. DoR in part 1 study

    Time frame: up to 2 years

    Duration of response (DoR) as assessed by the investigator per RECIST 1.1

  5. OS in part 1 study

    Time frame: up to 3 years

    Overall survival (OS)

  6. PFS in part 2 study

    Time frame: up to 3 years

    PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1

  7. ORR in part 2 study

    Time frame: up to 2 years

    ORR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1

  8. DCR in part 2 study

    Time frame: up to 2 years

    DCR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1

  9. DoR in part2 study

    Time frame: up to 2 years

    DoR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1

  10. PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator as per RECIST 1.1

    Time frame: up to 2 years

  11. ORR in part 2 study

    Time frame: up to 2 years

    ORR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1

  12. DCR in part 2 study

    Time frame: up to 2 years

    DCR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1

  13. DoR in part 2 study

    Time frame: up to 2 years

    DoR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1

  14. AEs and SAEs in part 2 study

    Time frame: up to 2 years

    Safety endpoints, including incidence and severity of AEs and SAEs as per NCI-CTCAE v5.0 criteria

  15. EORTC QLQ-C30 score

    Time frame: up to 2 years

  16. EORTC QLQ-STO22 score

    Time frame: up to 2 years

  17. EQ-5D-5L score

    Time frame: up to 2 years

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multi-Center, Phase III Clinical Study of SHR-1701 Plus Chemotherapy Versus Placebo Plus Chemotherapy as Treatment in Patients With Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Jul 6, 2021
Registry last updated
Mar 30, 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.