Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer

NCT05795296 | Unknown Phase 2

• 1 other identifier: HMPL-013-SH-GC-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. The main questions it aims to answer are:

• Does this therapy have a promising efficacy?
• Does this therapy have a manageable toxicity? Participants will receive fruquintinib plus sintilimab as first-line therapy for gastric cancer.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The proportion of patients with complete response or partial response, using RECIST v 1.1.

  12 months

Secondary Outcomes (4)

• Progression-Free Survival (PFS)

  12 months

• Overall survival (OS)

  12 months

• Disease Control Rate (DCR)

  12 months

• Adverse Events

  12 months

Study Arms (1)

Fruquintinib+Sintilimab

EXPERIMENTAL

Fruquintinib: 5mg po, d1-d14, q3w Sintilimab: 200mg ivgtt, d1, q3w

Drug: Fruquintinib; Drug: Sintilimab

Interventions

Fruquintinib DRUG

Fruquintinib: 5mg po, d1-d14, q3w

Fruquintinib+Sintilimab

Sintilimab DRUG

Sintilimab: 200mg ivgtt, d1, q3w

Fruquintinib+Sintilimab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological confirmed advanced, recurrent, of metastatic gastric adenocarcinoma or adenocarcinoma of esophagogastric junction;
• ECOG PS: 0-2;
• Adequate hepatic, renal, heart, and hematologic functions;
• At least one measurable lesion (according to RECIST1.1);
• Haven't received any systematic treatment for the cancer involved;
• Expected survival \> 12 weeks;
• Contraception until 6 months after the study termination;
• Signed informed consent.

You may not qualify if:

• Her-2-positive gastric cancer, or exposed to any immune checkpoint inhibitor;
• Participated in another study;
• Immunodeficiency;
• Received allograft；
• Unmanageable hypertension, diabetes, or coronary disease;
• Have difficulty in taking medicine, or active bleeding;
• Pulmonary tuberculosis, or interstitial lung disease that needs steroid therapy;
• Infection of HIV, HBV, HCV, or other unmanageable infection;
• Other malignant tumor history;
• Allergic to the test drug;
• Other diseases which will affect the results of this study;
• Received resection of stomach;
• Taking anti-tumor traditional Chinese Medicine;
• Severe active bleeding.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HMPL-013; sintilimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Shuiping Tu

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: December 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)