Clinical trial NCT04950322: A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric or Gastroesophageal Junction Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: AEs and SAEs in part 1 study
timeFrame: up to 2 years
measure: Overall survival in subjects with PD-L1 CPS ≥ 5 in part 2 study
timeFrame: up to 3 years
measure: OS in all subjects in part 2 study
timeFrame: up to 3 years
Secondary outcomes:
measure: ORR in part 1 study
timeFrame: up to 2 years
measure: DCR in part 1 study
timeFrame: up to 2 years
measure: PFS in part 1 study
timeFrame: up to 2 years
measure: DoR in part 1 study
timeFrame: up to 2 years
measure: OS in part 1 study
timeFrame: up to 3 years
measure: PFS in part 2 study
timeFrame: up to 3 years
measure: ORR in part 2 study
timeFrame: up to 2 years
measure: DCR in part 2 study
timeFrame: up to 2 years
measure: DoR in part2 study
timeFrame: up to 2 years
measure: PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator as per RECIST 1.1
timeFrame: up to 2 years
measure: ORR in part 2 study
timeFrame: up to 2 years
measure: DCR in part 2 study
timeFrame: up to 2 years
measure: DoR in part 2 study
timeFrame: up to 2 years
measure: AEs and SAEs in part 2 study
timeFrame: up to 2 years
measure: EORTC QLQ-C30 score
timeFrame: up to 2 years
measure: EORTC QLQ-STO22 score
timeFrame: up to 2 years
measure: EQ-5D-5L score
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: