Fruquintinib as a Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer

NCT ID: NCT04296019

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2025-01-01

Brief Summary

This study was a randomized, controled, multicenter, phase II clinical study evaluating the efficacy and safety of fruquintinib as a maintenance therapy following first-line treatment for metastatic colorectal cancer. This study will include the patients with confirmed unresectable metastatic left-sided colon cancer with RAS mutation or right-sided colon cancer who achieved stable disease (SD) or partial response (PR) or complete response (CR) via palliative first-line treatment. It's expected to include 110 patients and they will be randomly stratified at 2:1 into fruquintinib group and observation group based on whether bevacizumab is used and the primary tumor site, using the Interactive Network Response System (IWRS). The random No. corresponds to the respective patient. The enrollment time is expected to be 18 months, followed up for 24 months.

Conditions

Colo-rectal Cancer

Keywords

fruquintinib; Colo-rectal Cancer; maintenance therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fruquintinib

Patients who achieved stable disease (SD) or partial response (PR) or complete response (CR) following palliative first-line treatment will receive maintenance therapy with fruquintinib.

Group Type: EXPERIMENTAL

Fruquintinib

Intervention Type: DRUG

Maintenance therapy with fruquintinib ( 5 mg qd for 3 consecutive weeks, followed by discontinuation for 1 week).

Observation

Patients who achieved SD or PR or CR following palliative first-line treatment will receive treatment-free observation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fruquintinib

Maintenance therapy with fruquintinib ( 5 mg qd for 3 consecutive weeks, followed by discontinuation for 1 week).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18-75 years old (including 18 and 75 years);
• Eastern Cooperative Oncology Group-performance score (ECOG PS) 0 or 1;
• Estimated survival ≥ 6 months;
• Histologically and/or cytologically confirmed metastatic left-sided colon cancer with RAS mutation or right-sided colon cancer, having unresectable metastatic or recurrent foci;
• Having received first-line systemic anti-tumor therapy for mCRC (chemotherapeutic drugs may include fluorouracil, oxaliplatin, irinotecan, such as XELOX, FOLFOX, FOLFIRI, and can combine or not combine with bevacizumab); achieving RECIST1.1-assessed SD (stable disease) or PR (partial response) or CR (complete response) after 18-24 weeks of first-line treatment.
• UCG suggesting left ventricular ejection fraction ≥50%;
• Having fully understood and voluntarily signed the informed consent.

• Serum total bilirubin > 1.5 × upper limit of normal (ULN); > 2.5 × ULN for patients with hepatic metastases;
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 × ULN, or > 5 × ULN for patients with hepatic metastases;
• Serum creatinine > 1.5 × upper limit of normal (ULN), or creatinine clearance < 50mL / min (calculated using Cockcroft-Gault formula);
• Partial prothrombin time (APTT) or prothrombin time (PT) > 1.5 times ULN (based on the normal value in the clinical study center);
• Clinically significant electrolyte abnormalities;
• Urine protein 2+ or above, or 24-hour urinary protein quantity ≥ 1.0g / 24h;
• Subjects with dysphagia or known drug absorption disorders;
• Presence of brain metastasis or leptomeningeal metastasis;
• The toxicity of previous anticancer treatment has not yet reduced to (NCI CTC AE) level 1, excluding alopecia and oxaliplatin-induced neurotoxicity ≤ 2); patients haven't not fully recovered from previous surgery or less than 4 weeks elapsed since previous anticancer treatment or surgery;
• Patients have clinically detectable second primary malignant tumors at enrollment, or have other malignant tumors (except for well-treated basal cell carcinoma or cervical carcinoma in situ) in the past 5 years;
• Patients have clinically uncontrolled active infections such as acute pneumonia, hepatitis B or hepatitis C activity (previous history of hepatitis B infection, whether or not under medication control, HBV DNA ≥ 104 copies or ≥ 2000 IU/ml);
• Patients have hypertension that cannot be controlled by a single drug. That is, after single drug treatment, systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg;
• Patients currently have digestive tract diseases such as duodenal ulcer, ulcerative colitis, intestinal obstruction or other conditions that may cause gastrointestinal bleeding or perforation at the discretion of the investigator; or patients have undergone surgery for intestinal perforation and intestinal fistula but was uncured.
• Patients have a history of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, or patients have bleeding tendency or bleeding history within the 2 months before enrollment, regardless of severity;
• Patients have a stroke or transient ischemic attack within 12 months prior to enrollment;
• Skin wounds, surgical sites, trauma site, severe mucosal ulcers or fractures haven't completely healed yet.
• Patients have acute myocardial infarction, severe/unstable angina, coronary artery bypass grafting or NYHA Class II/more severe cardiac insufficiency within 6 months prior to enrollment;
• Pregnant or lactating women; or women with potentiality of childbearing have a positive pregnancy test result before the first dose;
• Patients have any clinical or laboratory abnormalities or compliance problems so that the investigator believes that they are not suitable to participate in this clinical study;
• Patients have serious psychological or mental abnormalities;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tianshu Liu

Director of Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tianshu Liu

Role: CONTACT

Phone: 021-13681973996

Email: liu.tianshu@zs-hospital.sh.cn

yiyi yu

Role: CONTACT

Phone: 021-13816730912

Email: yu.yiyi@zs-hospital.sh.cn

Facility Contacts

Tianshu Liu, Doctor

Role: primary

Other Identifiers

ZS-ON-09

Identifier Type: -

Identifier Source: org_study_id