A Prospective, Open-label, Single-arm Phase II Clinical Study of Fruquintinib Combined With S-1 for the Treatment of Metastatic Colorectal Cancer.

NCT06746545 | Not Yet Recruiting Phase 2

• 1 other identifier: F+S-1-CRC
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Exploring the efficacy and safety of fruquintinib combined with S-1 for second-line and beyond treatment in patients with advanced colorectal cancer.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Tumor assessment will be performed using radiography method every 6 weeks, until the occurrence of progressive disease (PD), using RECIST v 1.1

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

Secondary Outcomes (4)

• Objective response rate (ORR)

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

• Overall survival (OS)

  from randomization until death due to any cause, assessed up to 3 year

• Disease control rate (DCR)

  from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year]

• Safety and tolerance evaluated by incidence, severity and outcomes of AEs

  from first dose to 30 days post the last dose

Other Outcomes (1)

• Exploratory study endpoints.

  Perform ctDNA tests on patients' blood at the start, after the first three cycles of treatment, and when disease progresses,from randomization up to progressive disease or EOT due to any cause, assessed up to 2 year

Study Arms (1)

Experimental

EXPERIMENTAL

Drug: Fruquintinib+S-1

Interventions

Fruquintinib+S-1 DRUG

Fruquintinib: 5 mg, oral, once daily，2w/1w；Q3W S-1：40-60 mg (dosed according to body surface area), oral，2w/1w；Q3W

Experimental

Eligibility Criteria

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

You may qualify if:

• Fully understand this study and voluntarily sign the informed consent form;
• Age ≥18 years, gender not limited;
• Confirmed advanced metastatic colorectal adenocarcinoma by histopathological examination;
• Patients have previously received at least one line of standard therapy containing fluorouracil, oxaliplatin, and irinotecan, and have progressed or are intolerant.
• Each line of treatment must include one or more chemotherapy drugs for a duration of ≥1 cycle;
• Adjuvant/neoadjuvant therapy is allowed. If recurrence or metastasis occurs during or within 6 months after completion of adjuvant/neoadjuvant therapy, it is considered a failure of first-line chemotherapy for progressive disease;
• Prior use of chemotherapy combined with cetuximab or bevacizumab in antitumor treatment regimens is allowed;
• At least one measurable lesion (RECIST 1.1 criteria);
• ECOG performance status 0-1;
• Expected survival time ≥12 weeks;
• Within 14 days before enrollment, the function of major organs must meet the following requirements (no use of any blood components and cell growth factors within 14 days before enrollment):
• Absolute neutrophil count ≥1.5×10\^9/L;
• Platelet count ≥80×10\^9/L;
• Hemoglobin ≥8g/dL;
• Total bilirubin \<1.5 times the upper limit of normal (ULN);

You may not qualify if:

• Have previously received treatment with fruquintinib or other anti-VEGFR (vascular endothelial growth factor receptor) inhibitors such as apatinib, regorafenib, and anlotinib;
• Have previously received treatment with tegafur;
• Have participated in another drug clinical trial within four weeks before enrollment and received at least one dose of medication, or have received other systemic antitumor treatments, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy within four weeks before enrollment;
• Patients currently have diseases or conditions that affect drug absorption, or patients are unable to orally take fruquintinib;
• Patients currently have active gastric and duodenal ulcers, ulcerative colitis, and other gastrointestinal diseases, or have active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigator;
• Have active bleeding or bleeding tendencies;
• Have uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as not effectively controlled by diuretics or puncture as judged by the investigator);
• Have a history of severe cardiovascular and cerebrovascular diseases:
• Cerebral vascular accidents (except for lacunar infarction, minor cerebral ischemia, or transient cerebral ischemic attacks), myocardial infarction, unstable angina, poorly controlled arrhythmias (including QTc interval for males ≥ 450ms, females ≥ 470ms) (QTc interval calculated using the Fridericia formula) within 6 months before the first dose of the study drug;
• New York Heart Association (NYHA) heart function classification \> II or left ventricular ejection fraction (LVEF) \< 50%;
• Have had other malignancies in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
• Have clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (history of hepatitis B virus infection not under drug control, HBV DNA ≥1×10\^4 copies/mL or \>2000 IU/mL);
• Have clinically symptomatic central nervous system metastases and/or meningeal carcinomatosis;
• Patients currently have uncontrolled hypertension with medication, defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg after taking antihypertensive drugs;
• Urinalysis indicates urinary protein ≥2+, and re-examined 24-hour urinary protein quantity \>1.0g;

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

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

Jintian Song

CONTACT

13115915866; 249599337@qq.com

Study Design

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

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 24, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-02