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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Gastric or Gastroesophageal Junction Cancer
• Intervention / Treatment: Drug: SHR-1701、CAPOX; Drug: Placebo、CAPOX

• Study Type: Interventional
• Enrollment (Actual): 737
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 1000000
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: SHR-1701、CAPOX; SHR-1701 with CAPOX (CAPOX:Oxaliplatin,Capecitabine)
Placebo Comparator: Treatment group B	Drug: Placebo、CAPOX; Placebo with CAPOX (CAPOX:Oxaliplatin,Capecitabine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) .	up to 2 years
PFS in part 2 study assessed based on BICR	Progression-free survival(PFS) assessed based on BICR per RECIST 1.1	up to 2 years
OS in part 2 study	Overall survival (OS)	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR in part 1 study	Objective response rate (ORR) as assessed by the investigator per RECIST 1.1	up to 2 years
PFS in part 1 study	Progression free survival (PFS); as assessed by the investigator per RECIST 1.1	up to 2 years
DoR in part 1 study	Duration of response (DoR) as assessed by the investigator per RECIST 1.1	up to 2 years
OS in part 1 study	Overall survival (OS)	up to 3 years
ORR in part 2 study	ORR in subjects with PD-L1 positive and all subjects assessed by BICR per RECIST 1.1	up to 2 years
PFS in part 2 study assessed by investigator	PFS in subjects with PD-L1 positive and all subjects assessed by investigator as per RECIST 1.1	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.	up to 2 years
EORTC QLQ-C30 score		up to 2 years
EORTC QLQ-STO22 score		up to 2 years
EQ-5D-5L score		up to 2 years
DoR in part 2 study	DoR in subjects with PD-L1 positive and all subjects assessed by BICR per RECIST 1.1	up to 2 years

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1701-III-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No