Status:
RECRUITING
Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Lead Sponsor:
Hubei Cancer Hospital
Conditions:
Non Small Cell Lung Cancer
Locally Advanced
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our previous sturdy indicated that patients who received induction immunotherapy and subsequent radiotherapy s...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed non-small cell lung cancer;
- stage IIIA or IIIB or IIIC according to the 8th edition of the TNM cancer staging system of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control（UICC);
- inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy;
- After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
- performance status 0-1;
- measurable or evaluable lesions;
- Survival expectancy is not less than 6 months;
- adequate cardiac, pulmonary, renal, and hepatic and bone marrow function
Exclusion
- tumor progress after induction with immunothearoy and chemotherapy
- EGFR, ALK, or ROS1 mutation;
- Previous thoracic radiotherapy;
- grade 2 or more immune-related adverse events after induction immunotherapy
- Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);
- Pregnant or lactating women
- undergoing other clinical trials;
- Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;
- Patients with HIV positive and undergoing antiviral therapy;
- Active tuberculosis
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 8 2027
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06020430
Start Date
February 8 2024
End Date
October 8 2027
Last Update
March 15 2024
Active Locations (1)
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1
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079