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NCT06195670

PHASE1/PHASE2

Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine as First Line Treatment in Advanced mCRC

Sponsor: Zhejiang Cancer Hospital

View on ClinicalTrials.gov

Summary

The aim of this study is to evaluate the efficacy and safety of short course radiotherapy followed by fruquintinib combined with Sintilimab as the first-line treatment of advanced mCRC compared to bevacizumab combined with capecitabine in patients unfit for intensive therapy.

Official title: An Open-label, Multi-centered, Two-stage Clinical Study of Short-course Radiotherapy Followed by Fruquintinib Plus Sintilimab vs Bevacizumab Plus Capecitabine in the First Line Treatment of Advanced mCRC Patients Unfit for Intense Therapy

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2024-01

Completion Date

2027-01

Last Updated

2024-01-08

Healthy Volunteers

Conditions

CRC Metastatic Colorectal Cancer Metastatic Colorectal Adenocarcinoma

Interventions

DRUG

Experimental

SCRT: 5\*5Gy for 5 days, after a one-week rest, with fruquintinib plus sintilimab followed; Fruquintinib: qd po, 4mg/d, 2weeks on/1 week off, q3w; Sintilimab: intravenous infusion, 200mg, on day 1, q3w.

DRUG

Active Comparator

Capecitabine: bid po, 1000mg/m², on days 1-14, q3w; Bevacizumab: intravenous infusion, 7.5mg/kg, on day 1, q3w.

Inclusion Criteria: * Have signed an informed consent; * 18 to 85 years old (including 18 and 85 years old); * Histopathologically confirmed unresectable advanced metastatic colorectal adenocarcinoma; * Have not received anti-tumor treatment for metastatic disease; * Inability to tolerate intensive treatment regimens based on oxaliplatin or irinotecan as determined by researchers; * At least one measurable lesion; * Expected life expectancy ≥ 12 weeks; * The function of important organs within the 14 days prior to enrollment meets the following requirements (no blood components or cell growth factors are allowed to be used within the 14 days prior to enrollment): * Neutrophil absolute count ≥ 1.5 × 10\^9/L; * Platelets ≥ 80 × 10\^9/L; * Hemoglobin ≥ 8g/dL; * Total bilirubin\<1.5 times ULN; * ALT and AST\<2.5 times ULN (liver metastasis patients\<5 times ULN); * Serum creatinine ≤ 1.5 times ULN; * Endogenous creatinine clearance rate\>50ml/min; * International standardized ratio (INR) of coagulation function ≤ 1.5 × ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN * Women of childbearing age or men whose partners have a desire to conceive should take effective contraceptive measures. Exclusion Criteria: * Currently has a disease or condition that affects drug absorption, or the patient is unable to take oral drugs; * Currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation; * History of serious cardiovascular and cerebrovascular diseases; * Other malignant tumors within the past 5 years, excluding skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ; * Clinically uncontrolled active infection, such as acute pneumonia, active hepatitis B or hepatitis C (hepatitis B virus DNA ≥ 1 × 104 copies/mL or\>2000 IU/ml); * Currently has central nervous system (CNS) metastasis or has a history of unstable or clinically symptomatic brain metastasis; * Pregnant (positive pregnancy test before medication) or breastfeeding women; * Urine protein ≥ 2+, or 24-hour urine protein \>1.0g; * Histologically confirmed MSI-H/dMMR tumors; * Patients deemed unsuitable by the researchers for inclusion in this study.

Locations (1)

Ji Zhu

Hangzhou, Zhejiang, China