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

Phase 3Active Not RecruitingNCT04950322

Suzhou Suncadia Biopharmaceuticals Co., Ltd.737 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

737

Conditions

Gastric or Gastroesophageal Junction Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

AEs and SAEs in part 1 study

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).

Time frame: up to 2 years

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

Time frame: up to 3 years

OS in all subjects in part 2 study

Overall survival (OS)

Time frame: up to 3 years

Secondary Outcomes

ORR in part 1 study

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

Time frame: up to 2 years

DCR in part 1 study

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

Time frame: up to 2 years

PFS in part 1 study

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

Time frame: up to 2 years

DoR in part 1 study

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

Time frame: up to 2 years

OS in part 1 study

Overall survival (OS)

Time frame: up to 3 years

PFS in part 2 study

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

Time frame: up to 3 years

ORR in part 2 study

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

Time frame: up to 2 years

DCR in part 2 study

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

Time frame: up to 2 years

DoR in part2 study

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

Time frame: up to 2 years

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

ORR in part 2 study

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

Time frame: up to 2 years

DCR in part 2 study

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

Time frame: up to 2 years

DoR in part 2 study

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

Time frame: up to 2 years

AEs and SAEs in part 2 study

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

Time frame: up to 2 years

EORTC QLQ-C30 score

Time frame: up to 2 years

EORTC QLQ-STO22 score

Time frame: up to 2 years

EQ-5D-5L score

Time frame: up to 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes