Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06018714 |
Recruitment Status :
Recruiting
First Posted : August 31, 2023
Last Update Posted : August 31, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer Metastatic | Drug: Fruquintinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | This is a prospective, single-arm, phase II study aimed at exploring the clinical efficacy and safety of fruquintinib as maintenance therapy for advanced CRC patients who achieve NED after adjuvant chemotherapy. Patients will receive full supportive care while on this study. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Clinical Efficacy of Modified Fruquintinib as Maintenance Treatment for Colorectal Cancer Liver Metastases After NED: Phase II Single-arm Prospective Study |
Actual Study Start Date : | May 1, 2023 |
Estimated Primary Completion Date : | August 1, 2024 |
Estimated Study Completion Date : | August 1, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Fruquintinib group
Patients will receive Fruquintinib maintenance treatment for six months, or until tumor recurrence, metastasis, or intolerable drug toxicities occur within six months. After achieving no evidence of disease (NED), a chest, abdomen, and pelvic CT scan with contrast or a chest CT scan with abdominal and pelvic MRI scan will be performed every 6 months within 2 years. Colonoscopy will be performed annually. CEA, CA19-9, and abdominal and pelvic ultrasound will be performed every 3 months. If abnormalities are found, further imaging studies and colonoscopy will be conducted, and if necessary, a PET/CT scan will be performed. |
Drug: Fruquintinib
Drug: Maintenance treatment regimen: Fruquintinib 5 mg, qd, po, with three weeks of continuous treatment followed by one week of drug discontinuation. Each treatment cycle lasts four weeks. The treatment will be continued for six months, or until tumor recurrence, metastasis, or intolerable drug toxicities occur within six months. Adverse drug reactions that occur during the trial will be graded according to the NCI CTCAE version 5.0 and dose adjustments will be made according to the corresponding rules. |
- 2-year recurrence and metastasis rate [ Time Frame: 2 years after NED ]To evaluate the clinical efficacy and safety of fruquintinib as maintenance therapy for advanced CRC patients who achieve NED after adjuvant chemotherapy, with the 2-year recurrence and metastasis rate as the primary indicator.
- 2-year disease-free survival rate [ Time Frame: 2 years after NED ]To evaluate 2-year recurrence-free survival rate, 2-year overall survival rate, recurrence-free survival period in patients accepting fruquintinib maintenance therapy.
- completion rate of maintenance therapy [ Time Frame: 2 years after NED ]To evaluate safety and completion rate of maintenance therapy
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- . The pathological diagnosis was colorectal adenocarcinoma liver metastasis;
- . Age: 18 to 75 years old,allgenders;
- . Patients who have previously received first-line chemotherapy and have achieved disease control (PR+SD) according to RECIST 1.1;
- . Patients with liver metastasis of colorectal cancer who have undergone curative local treatment (surgery, ablation, SBRT) and achieved no evidence of disease (NED). Definition of NED: a. After local treatment, no residual signs of primary or metastatic tumors are observed on CT, MRI, PET-CT imaging, or b. No cancer cells are found in biopsies of suspicious lesions;
- .Completed adjuvant chemotherapy after achieving NED (e.g. 4-8 cycles of CapOX regimen, 6-12 cycles of FOLFOX regimen, or without receiving adjuvant chemotherapy recently) and evaluated as no disease progression. Last chemotherapy within 2 months from enrollment.
- . The time interval between the last chemotherapy and enrollment does not exceed 2 months;
- . Performance status (ECOG score) ≤ 2
- . Hematology: WBC > 3 × 10^9 / L; PLT > 80 × 10^9 / L; Hb > 90 g/L;
- . Liver function: ALT and AST ≤ 2.5 × ULN; bilirubin ≤ 1.5 × ULN;
- .Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;
- .Signed informed consent, willingness to undergo treatment according to this protocol, and good compliance with medication.
Exclusion Criteria:
- .Patients with tumor progression before enrollment following the completion of chemotherapy.
- .Intestinal obstruction or incomplete intestinal obstruction.
- .Co-existing with other serious illnesses, including severe electrolyte disorders, bleeding tendencies, etc.
- .Active or uncontrolled severe infections: a) Known human immunodeficiency virus (HIV) infection. b) Known clinically significant liver disease history, including viral hepatitis [known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (>1×104 copies/mL or >2000 IU/mL)]. c) Known hepatitis C virus (HCV) infection with positive HCV RNA (>1×103 copies/mL), or other hepatitis, liver cirrhosis.
- .Women who are pregnant or breastfeeding and have childbearing potential but are not taking adequate contraceptive measures.
- .Patients with severe brain disorders or mental illnesses (such as depression, mania, obsessive-compulsive disorder, and schizophrenia) that affect the patient's ability to self-report.
- .Patients with autoimmune diseases, blood system disorders, and a history of organ transplantation, long-term use of steroids, or immunosuppressive agents.
- .History of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin.
- .History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation).
- .Known or suspected allergies to the investigational drug fruquintinib.
- .Hypertension that cannot be well controlled with antihypertensive medications (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- .Active cardiac disease within 6 months prior to treatment, including myocardial infarction, severe/unstable angina pectoris. Left ventricular ejection fraction <50% on echocardiography, poorly controlled arrhythmias.
- .Urinalysis indicating urine protein ≥2+ and 24-hour urine protein quantification >1.0g.
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): NCT06018714
Contact: Junzhong Lin, Doctor | 020-87343533 | linjzh@sysucc.org.cn | |
Contact: Zhizhong Pan, Prof | 020-87343533 | panzhzh@sysucc.org.cn |
China, Guangdong | |
Colorectal Department,SunYat-sen University Cancer Center | Recruiting |
Guangzhou, Guangdong, China, 510062 | |
Contact: Junzhong lin, PhD +86-13802446666 linjzh@sysucc.org.cn |
Responsible Party: | ZHI-ZHONG PAN, Prof., Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT06018714 |
Other Study ID Numbers: |
2023-FXY-096-Department of CRC |
First Posted: | August 31, 2023 Key Record Dates |
Last Update Posted: | August 31, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colorectal cancer Fruquintinib |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |