Fruquintinib Plus Irinotecan in the Treatment of Advanced Gastric Cancer

NCT05643677 | Unknown Phase 2

• 1 other identifier: HMPL-013-E1-GC001
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study explores the efficacy and safety of fruquintinib combined with irinotecan in the second-line treatment of patients with advanced gastric cancer, aiming to bring more second-line treatment options for patients with advanced gastric cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS was defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (3)

• Objective remission rate (ORR)

  up to 12 months

• Disease control rate (DCR)

  up to 12 months

• Overall survival（OS）

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (1)

Fruquintinib combined with irinotecan

EXPERIMENTAL

Fruquintinib combined with irinotecan as a second-line treatment for advanced gastric cancer

Drug: Fruquintinib; Drug: Irinotecan

Interventions

Fruquintinib DRUG

4 mg PO, QD (3 weeks on, 1 week off)

Also known as: Elunate

Fruquintinib combined with irinotecan

Irinotecan DRUG

participants will receive irinotecan, 100 mg/m2, intravenous drip, day1 and day 14 of every 4 weeks

Fruquintinib combined with irinotecan

Eligibility Criteria

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

You may qualify if:

• Have fully understood this study and voluntarily signed informed consent;
• ≥18 years old;
• Histologically and/or cytologically confirmed metastatic or locally advanced gastric cancer or gastroesophageal conjunctive adenocarcinoma with at least one previous systemic therapy (note: Previous systemic treatment options approved by this protocol include single-drug or multi-drug combination chemotherapy or chemotherapy combined with immunotherapy, or failure of anti-HER-2 targeted therapy after positive HER-2);
• At least one extragastric measurable lesion according to RECIST v1.1 criteria;
• ECOG physical condition 0-1;
• BMI≥18；
• The expected survival time ≥12 weeks;
• The functions of vital organs during the first 14 days of enrollment met the following requirements:
• Neutrophil absolute count ≥1.5×109/L;
• Platelet ≥80×109/L;
• hemoglobin ≥90g/L;
• Total bilirubin \< 1.5 ULN;
• ALT and AST \< 2.5 ULN (\< 5 ULN in patients with liver metastasis);
• Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr)≥60ml/min;
• endogenous creatinine clearance \> 50ml/min;

You may not qualify if:

• Prior treatment with VEGF or VEGFR inhibitors;
• Past treatment with irinotecan (However, patients who had previously received neoadjuvant or failed postoperative adjuvant therapy could be included as first-line therapy）;
• Had participated in other drug clinical trials and received at least one drug therapy within 4 weeks prior to enrollment or had received other systemic antitumor therapy including chemotherapy, signal transduction inhibitors, immunotherapy, other investigational drugs;
• The patient has a current disease or condition that affects drug absorption, or the patient is unable to take fuquinitinib orally;
• Subjects who are allergic to the study drug or any of its adjuncts;
• Electrolyte abnormalities identified by the investigator as clinically significant;
• Hypertension that was not controlled by medication before enrollment was defined as: systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100 mmHg;
• Prior to enrollment, active gastric and duodenal ulcers, ulcerative colitis and other digestive diseases, active bleeding in unresectable tumors, or other conditions that researchers determined may cause gastrointestinal bleeding and perforation;
• Patients with significant evidence or history of bleeding tendency within 3 months prior to enrollment (bleeding within 3 months\>30 mL, hematemesis, black feces, hematochezia), hemoptysis (within 4 weeks\>5 mL fresh blood) or a thromboembolic event (including stroke and/or transient ischemic attack) within 12 months;
• History of severe cardiovascular and cerebrovascular diseases:
• Cerebrovascular accident (excluding lacunar infarction, mild cerebral ischemia or transient ischemic attack), myocardial infarction, unstable angina, and poorly controlled arrhythmia (including QTc interval ≥450ms for male and 470 ms for female) within 6 months before the first administration of the study drug (QTc interval ≥ 490ms for female) Fridericia formula);
• New York Heart Association (NYHA) Cardiac Function Rating \&gt; Grade II or left ventricular ejection fraction (LVEF) \< 50%;
• Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (previous history hepatitis B virus infection regardless of drug control, hepatitis B virus DNA≥1×104 copies /mL or \&gt; 2000 IU/ml);
• Symptomatic brain or meningeal metastases (except those with brain metastases that have undergone local radiotherapy or surgery for more than 6 months and whose disease control is stable);
• Women who are pregnant (tested positive for pregnancy before medication) or who are breastfeeding;

Sponsors & Collaborators

• Fujian Medical University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HMPL-013; Irinotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Xi Shi

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xi Shi

CONTACT

13960769368; ittsxi@163.com

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: archiater

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 9, 2022
• Study Start: December 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: December 9, 2022

Record last verified: 2022-12