A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy

NCT04866108 | Unknown Phase 2

• 1 other identifier: HMPL-013-FLAG-C104
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy.

Conditions

Unresectable Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1

  From Baseline to primary completion date, about 3 years

Secondary Outcomes (5)

• Overall Survival (OS)

  From Baseline to primary completion date, about 3 years

• Progression Free Survival (PFS)

  From Baseline to primary completion date, about 3 years

• Disease Control Rate (DCR)

  From Baseline to primary completion date, about 3 years

• Adverse Events and Serious Adverse Events

  From Baseline to primary completion date, about 3 years

• Quality of Life (QoL)

  From Baseline to primary completion date, about 3 years

Study Arms (1)

Experimental

EXPERIMENTAL

Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off

Drug: fruquintinib plus capecitabine

Interventions

fruquintinib plus capecitabine DRUG

oral fruquintinib plus capecitabine

Experimental

Eligibility Criteria

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

You may qualify if:

• ≥18 years old at the time of signing the informed consent;
• Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
• Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
• Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
• At least one measurable lesion(s);
• ECOG PS 0-2;
• Life expectancy≥3 months;
• Adequate organ and bone marrow functions;
• Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration;
• Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

You may not qualify if:

• Previous treatment with VEGFR inhibition;
• Participating in other drug clinical trials within 4 weeks before recruited;
• Have received other systemic anti-tumor therapies within 4 weeks before recruited;
• Non-controlled hypertension after monotherapy, that is, systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg;
• Proteinuria ≥ 2+ (1.0g/24hr);
• Clinically significant electrolyte abnormality;
• Clinically significant cardiovascular diseases;
• Thromboembolism or arteriovenous events occurred 6 months before recruited;
• ≥grade 3 bleeding events 4 weeks before recruited;
• Evidence of CNS metastasis;
• Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
• Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
• History of organ transplantation;
• APTT \>1.5×ULN or INR\>1.5;
• History of HIV infection or active hepatitis B / C;

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Wang X, Bai Z, Deng W, Wang X. Efficacy and safety of fruquintinib plus capecitabine as first-line treatment in patients with metastatic colorectal cancer ineligible for intravenous chemotherapy: a two-stage, single-armed, phase II study. Invest New Drugs. 2025 Apr;43(2):214-222. doi: 10.1007/s10637-025-01510-1. Epub 2025 Feb 13.

  PMID: 39945972 DERIVED

MeSH Terms

Interventions

HMPL-013; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Zhigang Bai

CONTACT

+86-010-63138712; baizhigang@ccmu.edu.cn

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: Professor

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: December 8, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)