The Efficacy and Safety of Fruquintinib Plus Chemotherapy as Second-line Treatment in Metastatic Colorectal Cancer
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| ClinicalTrials.gov Identifier: NCT05555901 |
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Recruitment Status :
Recruiting
First Posted : September 27, 2022
Last Update Posted : August 30, 2023
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Sponsor:
Fudan University
Information provided by (Responsible Party):
Xu jianmin, Fudan University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Colorectal Cancer | Drug: Fruquintinib+ chemotherapy Drug: Bevacizumab+ chemotherapy | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 116 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | fruquintinib plus chemotherapy vs bevacizumab plus chemotherapy |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Efficacy and Safety of Fruquintinib Combined With Chemotherapy vs Bevacizumab Combined With Chemotherapy as Second-line Treatment in Patients With Metastatic Colorectal Cancer: A Prospective, Multi-center, Randomized Study |
| Actual Study Start Date : | June 18, 2023 |
| Estimated Primary Completion Date : | September 2025 |
| Estimated Study Completion Date : | September 2025 |
Resource links provided by the National Library of Medicine
Drug Information
available for:
Bevacizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Fruquintinib+ chemotherapy
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.
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Drug: Fruquintinib+ chemotherapy
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 |
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Active Comparator: Bevacizumab+ chemotherapy
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.
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Drug: Bevacizumab+ chemotherapy
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 |
Primary Outcome Measures :
- Progression-Free Survival (PFS) [ Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year ]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
Secondary Outcome Measures :
- Objective response rate (ORR) [ Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year ]the proportion of patients with complete response or partial response, using RECIST v 1.1.
- Disease Control Rate (DCR) [ Time Frame: from randomization up to progressive disease or EOT due to any cause, assessed up to 1 year ]the proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
- Overall survival (OS) [ Time Frame: from randomization until death due to any cause, assessed up to 2 year ]time from randomization to death from any cause.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05555901
Contacts
| Contact: Jianmin Xu, MD | 86-21-6404-1990 ext 3449 | xujmin@aliyun.com |
Locations
| China, Fujian | |
| The First Hospital of Putian City | Not yet recruiting |
| Putian, Fujian, China, 351100 | |
| Contact: Yanchang Xu | |
| China, Hebei | |
| The Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital | Not yet recruiting |
| Shijiazhuang, Hebei, China, 050011 | |
| Contact: Guiying Wang | |
| China, Henan | |
| Henan Cancer Hospital | Not yet recruiting |
| Zhengzhou, Henan, China, 450008 | |
| Contact: Xiaobing Chen | |
| China, Hunan | |
| Xiangya Hospital of Central South University | Not yet recruiting |
| Changsha, Hunan, China, 410008 | |
| Contact: Shan Zeng | |
| China, Shandong | |
| Qilu Hospital of Shandong University (QLH) | Not yet recruiting |
| Jinan, Shandong, China, 250012 | |
| Contact: Yong Dai | |
| The Affiliated Hospital of Qingdao University | Not yet recruiting |
| Qingdao, Shandong, China, 266071 | |
| Contact: Wensheng Qiu | |
| China, Shanghai | |
| Renji hospital, Shanghai Jiaotong University | Not yet recruiting |
| Shanghai, Shanghai, China, 200001 | |
| Contact: Zizhen zhang, phd | |
| Changhai Hospital | Not yet recruiting |
| Shanghai, Shanghai, China, 200433 | |
| Contact: Wei Zhang | |
| Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School | Not yet recruiting |
| Shanghai, Shanghai, China, 201801 | |
| Contact: Ren Zhao | |
| China, Zhejiang | |
| the Second Affiliated Hospital of Medical College of Zhejiang University | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310000 | |
| Contact: Ying Yuan, Ph.D & MD | |
| Zhejiang Provincial People's Hospital | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310014 | |
| Contact: Zhiquan Qin | |
| Sir Run Run Shaw Hospital | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310016 | |
| Contact: Zhangfa Song | |
| China | |
| Zhongshan hosptial, Fudan University | Recruiting |
| Shanghai, China, 200032 | |
| Contact: Jianmin Xu, PhD +86-13501984869 xujmin@aiiyun.com | |
Sponsors and Collaborators
Fudan University
| Responsible Party: | Xu jianmin, Deputy director of the department of general surgery, Fudan University |
| ClinicalTrials.gov Identifier: | NCT05555901 |
| Other Study ID Numbers: |
FRESCO-3 |
| First Posted: | September 27, 2022 Key Record Dates |
| Last Update Posted: | August 30, 2023 |
| Last Verified: | August 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Xu jianmin, Fudan University:
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Fruquintinib plus Chemotherapy second-line treatment |
Additional relevant MeSH terms:
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Bevacizumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |