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.

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient voluntarily participates in the study, signs the informed consent form, and demonstrates good compliance;

Age 18 years or older (inclusive), regardless of gender;

Histologically and/or cytologically confirmed unresectable colorectal adenocarcinoma;

For left-sided colon cancer or rectal cancer patients, must be non-RAS wild-type;

Disqualifiers

Patients with known contraindications to Doxorubicin liposome, Oxaliplatin, Capecitabine, or Bevacizumab;

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.);

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);

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • Doxorubicin liposome combined with CapOX and Bevacizumab

    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.

Treatment groups

13 Participants
are divided into 1 treatment group
Group A: Doxorubicin liposome combined with CapOX and Bevacizumab regimen as first-line treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month progression-free survival (PFS)

Defined as the time between the first occurrence of disease progression (PD) or death after the patient receives the study drug, whichever occurs first.

Time frame
3 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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