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

S

Suzhou Suncadia Biopharmaceuticals

Status and phase

Active, not recruiting
Phase 3

Conditions

Gastric or Gastroesophageal Junction Cancer

Treatments

Drug: Placebo、CAPOX
Drug: SHR-1701、CAPOX

Study type

Interventional

Funder types

Industry

Identifiers

NCT04950322
SHR-1701-III-307

Details and patient eligibility

About

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.

Enrollment

737 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Pathologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ)adenocarcinoma.
  2. HER2 overexpression or amplification negative.
  3. Female or male, 18 years of age or above.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  5. 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

  1. Squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer.
  2. Presence of inadequately treated CNS metastases, or uncontrolled or symptomatic active CNS metastases ,leptomeningeal disease, and/or rapid progression.
  3. Presence of uncontrolled pleural effusion or ascites despite puncture drainage within 14 days prior to randomization.
  4. More than 20% weight loss within 2 months prior to randomization.
  5. Diagnosed with other malignant tumors within 5 years prior to enrollment.
  6. Presence of any active, known or suspected autoimmune disease.
  7. 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.
  8. Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

737 participants in 2 patient groups, including a placebo group

Treatment group A
Experimental group
Treatment:
Drug: SHR-1701、CAPOX
Treatment group B
Placebo Comparator group
Treatment:
Drug: Placebo、CAPOX

Trial contacts and locations

1

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Central trial contact

Linna Wang; Ting Lu

Data sourced from clinicaltrials.gov

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