Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer

NCT06255379 | Not Yet Recruiting Phase 2

• 2 other identifiers: ZF-2023-387-01HMPL-013-SC-CRC102
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC

Conditions

Metastasis Colorectal Cancer; Colon Cancer; Rectal Cancer

Keywords

Colorectal cancer; Fruquintinib; Tegafur Gimeracil Oteracil; mCRC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

  from randomization up to progressive disease or EOT due to any cause, up to 2 years

Secondary Outcomes (4)

• Objective response rate(ORR)

  from randomization up to progressive disease or EOT due to any cause, up to 2 years

• Disease control rate(DCR)

  from randomization up to progressive disease or EOT due to any cause, up to 2 years

• Overall survival (OS)

  from randomization up to progressive disease or EOT due to any cause, up to 3 years

• adverse events (AE)

  from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib

Study Arms (1)

Fuquinitinib +Tegafur Gimeracil Oteracil

EXPERIMENTAL

Drug: Fuquinitinib+Tegafur Gimeracil Oteracil

Interventions

Fuquinitinib+Tegafur Gimeracil Oteracil DRUG

Fuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)\< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 \< BSA （body surface area）\< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA（body surface area） \>1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w;

Fuquinitinib +Tegafur Gimeracil Oteracil

Eligibility Criteria

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

You may qualify if:

• ≥ 18 and ≤ 75 years of age;
• Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
• Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;
• Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
• ECOG performance status of 0-1;
• Life expectancy ≥ 12 weeks;
• No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);
• Adequate hepatic, renal, heart, and hematologic functions;
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

You may not qualify if:

• Pregnant or lactating women;
• Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
• Previous treatment with Tegafur Gimeracil Oteracil ;
• Participated in clinical trials of other drugs within four weeks before enrollment;
• Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
• International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN;
• Clinically significant electrolyte abnormalities;
• Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
• Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;
• Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;
• Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;
• History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;
• Stroke and / or transient cerebral ischemia occurred within 12 months before enrollment;
• Cardiovascular diseases with significant clinical significance;
• LVEF\<50%;

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; 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

Yang xiaobing, PhD

CONTACT

+86 135-8030-9705; yangxiaobing2002@126.com

Study Design

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

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): March 21, 2027
• Study Completion (Estimated): March 21, 2027
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)