The Efficacy and Safety of Fruquintinib Plus Chemotherapy as Second-line Treatment in Metastatic Colorectal Cancer

NCT05555901 | Unknown Phase 2

• 1 other identifier: FRESCO-3
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 13

Brief Summary

This is a prospective, multi-center, randomized study evaluating the efficacy and safety of fruquintinib combined with chemotherapy vs bevacizumab combined with chemotherapy as second-line treatment in patients with metastatic colorectal cancer. Patients will receive fruquintinib+ FOLFIRI or bevacizumab+FOLFIRI as the second-line treatment. After receiving 4-6 months of second-line treatment, patients who achieve disease control will receive fruquintinib + capecitabine or bevacizumab+ capecitabine as maintenance treatment. All patients will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal.

Conditions

Metastatic Colorectal Cancer

Keywords

Fruquintinib plus Chemotherapy; second-line treatment

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  time from randomization 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, assessed up to 1 year

Secondary Outcomes (3)

• Objective response rate (ORR)

  from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

• Disease Control Rate (DCR)

  from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year

• Overall survival (OS)

  from randomization until death due to any cause, assessed up to 2 year

Study Arms (2)

Fruquintinib+ chemotherapy

EXPERIMENTAL

Patients will receive fruquintinib+ FOLFIRI once every four weeks as the second-line treatment. After receiving 4-6 months of second-line treatment, patients who achieve disease control will receive fruquintinib + capecitabine as maintenance treatment.

Drug: Fruquintinib+ chemotherapy

Bevacizumab+ chemotherapy

ACTIVE COMPARATOR

Patients will receive bevacizumab+ FOLFIRI once every two weeks as the second-line treatment. After receiving 4-6 months of second-line treatment, patients who achieve disease control will receive bevacizumab + capecitabine as maintenance treatment.

Drug: Bevacizumab+ chemotherapy

Interventions

Fruquintinib+ chemotherapy DRUG

Second-line treatment : Fruquintinib+FOLFIRI Drug: Fruquintinib 4mg, orally, once daily, 3 weeks on/ 1 week off, q4w Drug: FOLFIRI regimen Irinotecan 180 mg/m2, and LV 400 mg/m2 followed by bolus 5-fluorouracil 400mg/m2 and a 46-48-hour continuous infusion 2400mg/m2 5-fluorouracil on day 1, q2w Maintenance treatment：Fruquintinib+Capecitabine Drug: Fruquintinib 4mg, orally, once daily, 2 weeks on/ 1 week off, q3w Drug: Capecitabine 825 mg/m2, orally, twice daily, q3w

Fruquintinib+ chemotherapy

Bevacizumab+ chemotherapy DRUG

Second-line treatment : Bevacizumab+FOLFIRI Drug: Bevacizumab 5mg/kg on day 1, q2w Drug: FOLFIRI regimen Irinotecan 180 mg/m2, and LV 400 mg/m2 followed by bolus 5-fluorouracil 400mg/m2 and a 46-48-hour continuous infusion 2400mg/m2 5-fluorouracil on day 1, q2w Maintenance treatment：Bevacizumab+Capecitabine Drug: Bevacizumab 7.5mg/kg on day 1, q3w Drug: Capecitabine 825 mg/m2, orally, twice daily, q3w

Bevacizumab+ chemotherapy

Eligibility Criteria

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

You may qualify if:

• Aged 18-75years (inclusive);
• Body weight ≥40 kg;
• Histological or cytological confirmed colorectal cancer;
• Expected survival \>12 weeks;
• Fail in previous first-line standard therapy, which must include a fluorouracil (5-fluorouracil or capecitabine), oxaliplatin ;
• At least one measurable lesion (according to RECIST1.1);
• Adequate hepatic, renal, heart, and hematologic functions;
• Negative serum pregnancy test at screening for women of childbearing potential.

You may not qualify if:

• Received radiation therapy, surgical procedure, chemotherapy, immunotherapy or molecular targeted therapy, or other investigational drugs within 4 weeks prior to treatment
• Prior treatment with anti-angiogenic small molecule targeted drugs, such as fruquintinib, etc
• Prior treatment with an irinotecan-based chemotherapy regimen
• Symptomatic brain or meningeal metastases (except for patients with BMS who have received local radiotherapy or surgery for more than 6 months and whose disease is stable);
• Patients with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
• Have obvious clinical bleeding symptoms or obvious bleeding tendency within 3 months before treatment (bleeding \> 30 mL within 3 months, hematemesis, black feces, hematozoia), hemoptysis (fresh blood \> 5 mL within 4 weeks), etc. Treatment for venous/venous thrombosis events within the previous 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day);
• Tumor invasion of large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava, was found during screening, which was judged by the investigator to have a greater risk of bleeding;
• Active heart disease, including myocardial infarction, severe/unstable angina, 6 months prior to treatment. Echocardiography examination left ventricular ejection fraction \< 50%, arrhythmia control is not good;
• The patient has had other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
• Allergy to the study drug or any of its excipients;
• Severe infection with active or uncontrolled infection;
• Any other disease, with clinical significance of metabolic abnormalities, abnormal physical examination or laboratory abnormalities, according to researchers, there is reason to suspect the patient has not suitable for the use of study drugs of a disease or condition (such as have a seizure and require treatment), or will affect the interpretation of results, or to make patients in high-risk situations;
• Urine routine showed urine protein ≥2+, and 24-hour urine protein level \>1.0g.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (13)

The First Hospital of Putian City

Putian, Fujian, 351100, China

NOT YET RECRUITING

The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital

Shijiazhuang, Hebei, 050011, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

NOT YET RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

NOT YET RECRUITING

Qilu Hospital of Shandong University (QLH)

Jinan, Shandong, 250012, China

NOT YET RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266071, China

NOT YET RECRUITING

Renji hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200001, China

NOT YET RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School

Shanghai, Shanghai Municipality, 201801, China

NOT YET RECRUITING

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

NOT YET RECRUITING

Zhongshan hosptial, Fudan University

Shanghai, 200032, 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

Jianmin Xu, MD

CONTACT

86-21-6404-1990; xujmin@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of the department of general surgery

Model Details: fruquintinib plus chemotherapy vs bevacizumab plus chemotherapy

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: June 18, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

CN (13)