Fruquintinib Combined With mFOLFOX6/FOLFIRI in First-line Treatment for Metastatic Colorectal Cancer

NCT05004441 | Unknown Phase 2 DMC

• 1 other identifier: HCCSC C02
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Fruquintinib Combined With mFOLFOX6/FOLFIRI as the first-line treatment of Metastatic Colorectal Cancer

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

  36 months

Secondary Outcomes (4)

• disease control rate (DCR)

  36 months

• Progression-Free Survival (PFS)

  36 months

• overall survival (OS)

  36 months

• adverse events (AE)

  36 months

Study Arms (1)

First-line treatment

EXPERIMENTAL

First-line treatment: Fruquintinib Combined With mFOLFOX6/FOLFIRI for twelve cycles. Maintenance treatment: Fruquintinib and Capecitabine

Drug: Fruquintinib Combined With mFOLFOX6/FOLFIRI

Interventions

Fruquintinib Combined With mFOLFOX6/FOLFIRI DRUG

Fruquintinib (3mg) will be given p.o. daily

First-line treatment

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years, ≤75 years
• Histologically confirmed unresectable or metastatic stage colorectal cancer
• Known RAS activating mutation/wild type and BRAF wild type;
• Patients have not received systematic treatment for unresectable or metastatic colorectal cancer (those who have received adjuvant or neoadjuvant chemotherapy with one regimen and relapsed more than 12 months after the end of chemotherapy can be enrolled);
• At least one measurable disease according to RECIST 1.1 guidelines for solid tumors；
• BMI≥18；
• ECOG 0-1
• Life expectancy \> 12 weeks
• Patients must have adequate organ function
• 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;
• Informed consent has been signed.

You may not qualify if:

• Have received other systemic anti-tumor therapies within 2 weeks before recruited(eg.chemotherapy or radiotherapy, immunotherapy, biological or hormonal therapy, or any VEGFR inhibitor treatment);
• Known BRAF activating mutation
• systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs;
• Clinically significant electrolyte abnormality;
• Proteinuria ≥ 2+ (1.0g/24hr);
• Patients have untreated central nervous system metastasis;
• Patients have not recovered from all toxicities associated with prior anti-tumor therapy ,to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE v5.0) Grade of 0 or 1, except for alopecia and oxaliplatin induced neurotoxicity ≤ 2 , and the previous surgery did not recover completely;
• Have received other systemic anti-tumor therapies within 4 weeks before recruited;
• Clinical uncontrolled active infections, such as acute pneumonia and active hepatitis B / C (previous history of hepatitis B virus infection, whether drug controlled or not, HBV DNA ≥ 104) × Copy number or ≥ 2000 IU / ml);
• Dysphagia or known malabsorption of drugs;
• Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
• Have evidence or history of bleeding tendency within 2 months after enrollment, the researcher assessed that moderate or severe bleeding tendency was not suitable for enrollment;
• Stroke (including transient ischemic attack) occurred within 12 months before admission;
• Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
• Pregnant or lactating women;

Sponsors & Collaborators

• Zhou Fuxiang: lead
• Hubei Cancer Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Huangshi Central Hospital: collaborator

Study Sites (1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Fuxiang Zhou, M.D.

CONTACT

+86-027-67813155; happyzhoufx@sina.com

Wenbo Wang, M.D.

CONTACT

+86-027-67813215; wangwenbo@whu.edu.cb

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: July 22, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)