Bevacizumab After Chemoradiotherapy For Locally Advanced Lung Adenocarcinoma

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective phase II study is to determine the efficacy and safety of bevacizumab maintenance therapy after concurrent chemoradiotherapy in locally advanced lung adenocarcinoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Pathologic confirmation of lung adenocarcinoma

• Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• Unresectable, refusing surgery or after R2 surgery ,confirmed by PET-CT or chest and abdominal CT, craniocerebral MRI, and ECT.

• After radiotherapy and chemotherapy, the tumor is in partial remission, complete remission or stable.

• 1-2 months after chemoradiotherapy ends.

• Organ and bone marrow functions were normal within the first 30 days of enrollment, including: • AST, ALT≤ 2.5*ULN or ≤5*ULN (with liver metastasis); • TBil ≤ 1.5 ULN • neutrophils absolute value ≥500 cells/mm3 • creatinine clearance ≥45 mL/min ;• platelets≥50,000 cells/mm3.

• CB6 within normal limits

• Patients and their family signed the informed consents

Exclusion Criteria:

• Lung squamous carcinoma.

• The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava).

• The tumor was associated with a cavity over 2cm in diameter.

• Bleeding tendency or coagulation disorder.

• Patients with hemoptysis (1/2 teaspoon blood/day) within 1 month.

• Full-dose anticoagulation therapy was used within the past 1 month.

• Severe vascular disease occurred within 6 months.

• Gastrointestinal fistula, perforation or abdominal abscess occurred within 6 months.

• Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months.

• Uncontrolled hypertension (systolic > 150mmHg and/or diastolic > 100mmHg).

• Major surgery within 28 days or minor surgery or needle biopsy within 48 hours.

• Urine protein 3-4+, or 24h urine protein quantitative >1g.

• Degree 3 esophagitis after chemoradiotherapy has not recovered.

• Elderly patients (age 75 years).

• The investigator does not consider the participant to be eligible for this study.