Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
ID06329973

Safety and Efficacy Study of Fruquintinib Combined With Sintilimab and CAPEOX as First-line Treatment for Advanced Unresectable or Metastatic Gastric/Gastroesophageal Junction Cancer

Led by Henan Cancer Hospital ยท Updated on 2025-07-17

70

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying a first-line treatment combining fruquintinib, sintilimab, and CAPEOX chemotherapy for adults with unresectable or postoperative recurrent advanced gastric or gastroesophageal junction adenocarcinoma. This single-arm, open-label Phase Ib/II trial aims to assess the safety and effectiveness of this combination, exploring its impact on tumor immune response and vascular normalization. The study also investigates molecular markers and tumor changes to better understand and improve treatment outcomes. Participants receive varying doses of fruquintinib combined with the PD-1 inhibitor sintilimab and CAPEOX chemotherapy, which includes oxaliplatin and capecitabine. The trial evaluates the best dose of fruquintinib during the first 21 days and continues treatment as part of the comprehensive plan. This approach is designed to enhance chemotherapy delivery and reactivate the body's immune response against the tumor. During the study, participants undergo regular assessments including measurement of tumor response, survival rates, progression, and side effects over up to 48 months. Researchers will monitor treatment safety up to 30 days after the last dose and analyze molecular biomarkers related to treatment effects. Participants' organ function, tumor changes, and overall health status are closely followed to evaluate the therapy's impact and identify potential benefits.

CONDITIONS

Brief Title

Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years (including 18 and 75)
  • Understand the study and voluntarily sign informed consent
  • Confirmed incurable advanced or recurrent gastric or gastroesophageal junction adenocarcinoma that is HER2-negative or unknown
  • At least one measurable tumor lesion according to RECIST 1.1 criteria
  • No prior treatment with VEGFR-targeting drugs or PD-1/PD-L1 monoclonal antibodies
  • Physical condition score (ECOG) of 0 or 1
  • Expected survival of 3 months or more
  • Good organ function with specific blood counts and liver, kidney, heart, and thyroid function within defined limits
  • Weight at least 40 kg or BMI over 18.5
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study
  • Men must agree to use effective contraception during and after the study
Not Eligible

You will not qualify if you...

  • History of other malignant tumors unless cured early-stage tumors unlikely to affect short-term survival
  • Participation in another drug clinical trial within 4 weeks
  • Conditions affecting oral medication intake like swallowing difficulties or chronic diarrhea
  • Recent significant bleeding events within 4 weeks
  • Known or suspected central nervous system metastasis
  • Poorly controlled hypertension or serious heart conditions
  • Long-term unhealed wounds or fractures
  • Tumor invasion into major blood vessels with high risk of fatal bleeding
  • Abnormal coagulation or recent use of certain anticoagulant drugs
  • Recent arterial or venous thrombosis events within 6 months
  • Significant proteinuria
  • Prior immunotargeted therapy
  • History of immunodeficiency or organ transplantation
  • Lung infections requiring steroids
  • Serious chronic autoimmune or inflammatory diseases
  • Hypersensitivity to monoclonal antibodies
  • History of substance abuse or mental disorders
  • Symptomatic pleural or abdominal fluid requiring intervention
  • Noncompliance with medical advice or incomplete data
  • Serious concurrent diseases threatening safety or study completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 48 months or until disease progression or discontinuation

Participants receive fruquintinib combined with sintilimab and CAPEOX as first-line treatment for advanced unresectable or metastatic gastric/gastroesophageal junction cancer.

Visits scheduled according to treatment cycles

Follow-up

Duration - Up to 30 days after last dose or until initiation of new anticancer therapy

Participants are monitored for safety and efficacy outcomes after treatment ends.

Approximately 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Henan Cancer Hospital

Zhengzhou, Henan, China, 450008

Actively Recruiting

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Research Team

X

Xiaobing Chen

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Single-arm, open-label, multicentre phase 1b/2 study to evaluate the safety and efficacy of fruquintinib combined with sintilimab and CAPEOX as a first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma (FUNCTION study): a study protocol.

Beibei Chen, Jing Zhao, Huifang Lv...

https://pubmed.ncbi.nlm.nih.gov/41005780