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.

NCT ID: NCT06753721

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2027-06-01

Brief Summary

This is a prospective, single-arm clinical study designed to evaluate the 6-month progression-free survival rate (6-month PFS rate) of Doxorubicin liposome combined with CapOX and Bevacizumab regimen as first-line treatment for advanced colorectal adenocarcinoma with SMAD4R361H/C mutation. The study plans to recruit 13 patients. After receiving 8 cycles of induction therapy, patients whose efficacy is evaluated as complete response (CR), partial response (PR), or stable disease (SD) (according to RECIST 1.1) will enter maintenance therapy.

Conditions

Advanced Colorectal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doxorubicin liposome combined with CapOX and Bevacizumab regimen as first-line treatment

6-month progression-free survival rate (6-month PFS rate) of Doxorubicin liposome combined with CapOX and Bevacizumab regimen as first-line treatment for advanced colorectal adenocarcinoma with SMAD4R361H/C mutation.

Group Type: EXPERIMENTAL

Doxorubicin liposome combined with CapOX and Bevacizumab

Intervention Type: DRUG

Bevacizumab (7.5 mg/kg, IV, Day 1) + Oxaliplatin (130 mg/m², IV, Day 1) + Capecitabine (1000 mg/m², oral, twice daily, for 14 days) + Doxorubicin liposome (20 mg/m², IV, Day 1), repeated every 3 weeks.

Interventions

Doxorubicin liposome combined with CapOX and Bevacizumab

Bevacizumab (7.5 mg/kg, IV, Day 1) + Oxaliplatin (130 mg/m², IV, Day 1) + Capecitabine (1000 mg/m², oral, twice daily, for 14 days) + Doxorubicin liposome (20 mg/m², IV, Day 1), repeated every 3 weeks.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

shi min MD,PHD

Role: CONTACT

Phone: 86-20-62787731

Email: nfyyshimin@163.com

Other Identifiers

NFEC-2024-310

Identifier Type: -

Identifier Source: org_study_id