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

Sponsor
RenJi Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05795296
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
33
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of Fruquintinib in Combination With Sintilimab as a First-line Therapy in Gastric Adenocarcinoma/Adenocarcinoma of Esophagogastric Junction
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fruquintinib+Sintilimab

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

Drug: Fruquintinib
Fruquintinib: 5mg po, d1-d14, q3w

Drug: Sintilimab
Sintilimab: 200mg ivgtt, d1, q3w

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [12 months]

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

Secondary Outcome Measures

  1. Progression-Free Survival (PFS) [12 months]

    Time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

  2. Overall survival (OS) [12 months]

    Time from randomization to death from any cause.

  3. Disease Control Rate (DCR) [12 months]

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

  4. Adverse Events [12 months]

    Adverse event assessed according to CTCAE v5.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renji Hospital Shanghai China 200000

Sponsors and Collaborators

  • RenJi Hospital

Investigators

  • Principal Investigator: Shuiping Tu, RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shuiping Tu, Prof., RenJi Hospital
ClinicalTrials.gov Identifier:
NCT05795296
Other Study ID Numbers:
  • HMPL-013-SH-GC-101
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 5, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of Apr 5, 2023