Last updated: March 2, 2023
Sponsor: Sun Yat-sen University
Overall Status: Completed
Phase
2
Condition
Adenocarcinoma
Non-small Cell Lung Cancer
Lung Cancer
Treatment
N/AClinical Study ID
NCT03904563
GASTO-1046
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Pathologic confirmation of lung adenocarcinoma
- Patients have measurable or evaluable lesions based on the Response EvaluationCriteria 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 andabdominal CT, craniocerebral MRI, and ECT.
- After radiotherapy and chemotherapy, the tumor is in partial remission, completeremission 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≤ 2.5ULN or ≤5ULN (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
Exclusion Criteria:
- Lung squamous carcinoma.
- The tumor has completely approached, encircled, or invaded the intravascular space ofthe 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 Yorkclass II or above), active cerebrovascular disease or cardiovascular disease occurredwithin 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.
Study Design
Total Participants: 27
Study Start date:
January 01, 2019
Estimated Completion Date:
December 15, 2022
Study Description
Connect with a study center
Sun yat-sen University Cancer Center
Guangzhou, Guangdong 510000
ChinaSite Not Available

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