Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

NCT05024812 | Unknown Phase 1

• 1 other identifier: HMPL-013-FLAG-G102
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label, multicenter, single arm phase Ⅰb/Ⅱ clinical study aims to explore the efficacy and safety of fruquintinib combined with toripalimab and SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.

Conditions

Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• DLTs

  DLTs are defined as grade 3 or higher adverse events that are related to fruquintinib during the first cycle of therapy.

  At the end of Cycle 1 (each cycle is 28 days)

• RP2D

  Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

  At the end of Cycle 1 (each cycle is 28 days)

• PFS

  PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

  about 2 years

Secondary Outcomes (5)

• OS

  about 2 years

• ORR

  about 2 years

• DCR

  about 2 years

• DoR

  about 2 years

• adverse events (AEs) categorized by severity in accordance with the NCI CTC AE Version 5.0

  about 2 years

Study Arms (1)

Experimental

EXPERIMENTAL

fruquintinib + toripalimab + SOX

Drug: fruquintinib＋toripalimab + SOX

Interventions

fruquintinib＋toripalimab + SOX DRUG

phase Ib: fruquintinib (dose finding): L1: 3 mg/d，L2: 4 mg/d，L3: 5 mg/d, qd po, D1-14, Q3W toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m\^2, ivgtt 2h, D1,Q3W. phase II: fruquintinib: RP2D toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m\^2, ivgtt 2h, D1,Q3W.

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically determined unresectable advanced gastric or gastroesophageal junction adenocarcinoma;
• years old (including 18 and 75 years old);
• No previous anti-tumor treatment for metastatic diseases;
• HER2 negative;
• Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
• Life expectancy ≥ 3 months;
• At least one measurable lesion according to RECIST version 1.1;
• Adequate organ and bone marrow functions:
• Absolute neutrophil count≥1.5x10\^9/L; Platelet count≥100x10\^9/L; Hemoglobin≥9g/dL; Serum bilirubin≤1.5x the upper limit of normal(ULN); Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤1.5x ULN; Serum creatinine≤1.5x ULN; Endogenous creatinine clearance rate ≥ 50ml / min;
• Women of childbearing age need to take effective contraceptive measures.

You may not qualify if:

• Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous use of immune checkpoint inhibitors;
• Other malignant tumors in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
• There was central nervous system (CNS) metastasis or previous brain metastasis before enrollment;
• Patients with autoimmune diseases or history of autoimmune diseases within 4 weeks before enrollment;
• Previously received allogeneic bone marrow transplantation or organ transplantation;
• Uncontrolled malignant ascites;
• Participated in other unapproved or unlisted drug clinical trials in China within 4 weeks before enrollment, and received corresponding experimental drug treatment;
• Cardiovascular disease, including unstable angina or myocardial infarction, occurred within 6 months before the start of study treatment;
• Subjects allergic to the study drug or any of its adjuvants;
• International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN；
• The researchers judged clinically significant electrolyte abnormalities;
• At present, the patient has hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
• Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment);
• Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
• Any disease or state affecting drug absorption before enrollment, or the patient cannot take oral medication;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Feng Wang, M.D.

CONTACT

860013938244776; fengw010@163.com

Qingxia Fan, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 27, 2021
• Study Start: June 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: February 1, 2025
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)