An Open-label, Multicenter, Single-arm Clinical Study on the Use of Doxorubicin Liposome in Combination With CapOX and Bevacizumab Regimen for First-line Treatment of Advanced Colorectal Adenocarcinoma With SMAD4R361H/C Mutation.

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with advanced colorectal cancer that has a specific genetic mutation called SMAD4R361H/C. The researchers want to see how well a combination of three drugs—Doxorubicin liposome, CapOX (which includes Oxaliplatin and Capecitabine), and Bevacizumab—works as a first-line treatment. They plan to enroll 13 participants who meet certain criteria, such as being 18 years or older, having confirmed advanced colorectal cancer that cannot be surgically removed, and having not received any prior chemotherapy.

Participants in this study will receive eight cycles of the treatment, and after that, their response will be assessed to see if they had a complete or partial response or if their disease remains stable. If their condition is evaluated positively, they will enter a maintenance phase. It’s important to note that the trial is not yet recruiting patients, and there are strict guidelines regarding who can participate, including health tests and no recent history of certain medical conditions. This ensures that the study is safe and that the results will be meaningful.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient voluntarily participates in the study, signs the informed consent form, and demonstrates good compliance;
• • 2. Age 18 years or older (inclusive), regardless of gender;
• • 3. Histologically and/or cytologically confirmed unresectable colorectal adenocarcinoma;
• • 4. For left-sided colon cancer or rectal cancer patients, must be non-RAS wild-type;
• • 5. Non-dMMR/MSI-H;
• • 6. SMAD4R361H/C mutation;
• • 7. No prior history of systemic chemotherapy;
• • 8. ECOG performance status of 0 or 1;
• • 9. Hematological tests (within 14 days without blood transfusion): neutrophil absolute count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, hemoglobin ≥ 90 g/L;
• • 10. Liver function tests (AST and ALT ≤ 3 × ULN, bilirubin ≤ 1.5 × ULN; if liver metastasis is present, AST and ALT ≤ 5 × ULN);
• • 11. Renal function (serum creatinine ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60 mL/min);
• • 12. Both male and female subjects of reproductive age must use effective contraception.
• Exclusion Criteria:
• • 1. Patients with known contraindications to Doxorubicin liposome, Oxaliplatin, Capecitabine, or Bevacizumab;
• • 2. Patients who have received radiotherapy or any anti-tumor treatments (chemotherapy, targeted therapy, immunotherapy, radiofrequency ablation, traditional Chinese medicine with anti-tumor indications, immunomodulators, or tumor embolization, etc.);
• • 3. Patients who have had other malignancies within the past 5 years or have concurrent malignancies (except for cured skin basal cell carcinoma and carcinoma in situ of the cervix);
• • 4. Patients who have experienced significant clinical bleeding symptoms, obvious bleeding tendency, or hemoptysis within 3 months prior to treatment, or who have had venous/thrombotic events such as cerebrovascular accidents (including transient ischemic attacks, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within the previous 6 months; or require long-term anticoagulation treatment with warfarin or heparin, or require long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day);
• • 5. Patients with active cardiovascular diseases within 6 months before treatment, including myocardial infarction, severe/uncontrolled angina. Echocardiography showing left ventricular ejection fraction \<50%, or poorly controlled arrhythmia;
• • 6. Known history of primary immunodeficiency virus infection;
• • 7. Patients with active or uncontrolled severe infections;
• • 8. Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities, and based on the investigator's judgment, there is reasonable suspicion that the patient has a condition or disease that is unsuitable for the use of the study drug;
• • 9. Any situation that, in the investigator's opinion, could pose a risk to the patient receiving study drug treatment, interfere with the assessment of the study drug's safety, or affect the interpretation of results.