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

Launched by ZHEJIANG CANCER HOSPITAL · Dec 22, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with advanced metastatic colorectal cancer (mCRC) who are not able to undergo more aggressive therapies. Specifically, the study aims to compare two treatment options: one that combines short-course radiotherapy with fruquintinib and sintilimab, and another that pairs bevacizumab with capecitabine. The goal is to see which combination is more effective and safer for patients starting treatment.

To participate in this trial, individuals should be between 18 and 85 years old and have a confirmed diagnosis of advanced mCRC that cannot be surgically removed. They must not have received other treatments for their cancer before this study and should be unable to tolerate more intense therapies. Participants will undergo tests to ensure their vital organ functions are stable before starting the trial. While the study is not yet recruiting, potential participants can expect thorough monitoring and care throughout the treatment process. It’s important to note that this trial excludes those with certain health conditions that could complicate treatment, such as active infections or severe heart problems.

Gender

ALL

Eligibility criteria

• 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.