Clinical trial NCT06871527: Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer
Official title: Fruquintinib Combined With Tislelizumab and FOLFOX as First-Line Treatment For Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Open-label, Phase Ib/II Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gastric (Stomach) Cancer
Gastric Adenocarcinoma
Fruquintinib
PD-1 Inhibitor
Tislelizumab
GEJ Adenocarcinoma
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old (including 18 and 75 years old);
* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
* Pathologically determined gastric or gastroesophageal junction adenocarcinoma;
* Advanced patients with radiographic confirmation of inoperable complete resection;
* No previous anti-tumor treatment for metastatic diseases;
* At least one measurable lesion according to RECIST version 1.1;
* Ability to take medications orally;
* No active bleeding;
* Adequate organ functions:

Absolute neutrophil count ≥2×109/L; Platelet ≥100×109/L; Hemoglobin ≥90g/L; WBC≥4×109/L Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN ； Serum creatinine (Cr) ≤1.5XULN；

• Have fully understood the study and voluntarily signed the informed consent;

Exclusion Criteria:

* Patients who had received any drug in the study protocol in the last year;
* Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;
* HER2 positive（HER-2 3+, or HER-2 2+ and FISH+）;
* Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
* Patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment;
* Patients with massive pleural or peritoneal effusion requiring drainage;
* Patients with severe ECG abnormalities or heart diseases (such as cardiac insufficiency, myocardial infarction, angina pectoris) that affect clinical treatment;
* Severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
* Mental disorders or central nervous system diseases or brain metastases affecting clinical treatment;
* Patients with autoimmune diseases;
* Patients with grade 3 or higher bleeding within 4 weeks;
* Patients with a history of allergy to any drug, similar drug or vehicle in this study;
* Had a major surgical procedure (thoracotomy, or laparotomy , etc.) within 4 weeks prior to the first dose of study therapy;
* Patients with nonhealed wounds, ulcers, or fractures;
* Patients who required systemic corticosteroids (excluding temporary testing, prophylactic administration for anaphylaxis), or immunosuppressive agents or had received such agents within 14 days before enrollment;
* Pregnant or lactating women, or patients of childbearing age who refused contraception during the study period;
* Investigators believe that the patient has any other conditions that are not suitable for participating in the study.

Primary outcomes:
measure: Phase Ib: Maximum tolerated dose (MTD)
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Phase Ib: RD
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Six-month progression-free survival
timeFrame: At six months
Secondary outcomes:
measure: PFS
timeFrame: Up to 3 years
measure: OS
timeFrame: Up to 3 years
measure: ORR
timeFrame: Up to 3 years
measure: DCR
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: