Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Cancer Hospital
About this trial
To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III Non-Small Cell Lung Cancer
Eligibility criteria
Qualifiers
Sign a written Informed Consent Form (ICF) and be able to comply with the visit and related procedures specified in the protocol.
Age ≥ 18 years old.
Primary non-small cell lung cancer (including adenocarcinoma and squamous cell carcinoma) diagnosed by cytology or histology.
According to the International Association for the Study of Lung Cancer and the Joint Committee on Cancer Classification 8th edition (AJCC8) TNM staging classification of lung cancer, the clinical staging is IIB (primary tumor>4cm), IIIA, or IIIB (resectable N2 only) stage. Resectable N2 refers to non bulk (defined as a short diameter less than 3cm), discrete, or single site N2 involvement. If clinically suspected as N2 or N3, pathological confirmation is required.
Disqualifiers
1. Histological and pathological examinations show the presence of coexisting small cell carcinoma, large cell neuroendocrine tumor, and sarcomatoid tumor components.
Active infection (requiring treatment with anti infective drugs or having used systemic anti infective drugs within the week prior to randomization);
Congestive heart failure [New York Heart Association (NYHA) classification ≥ II]; Serious arrhythmias, liver, kidney or metabolic diseases that require medication treatment;
Untreated coronary atherosclerotic heart disease; Type I or II respiratory failure; History of gastrointestinal perforation and/or fistula, intestinal obstruction, extensive intestinal resection, or long-term chronic diarrhea within the past 6 months.
Trial design
Treatments tested in this trial
- Experimental
- Active comparator
Treatment groups
86 Participants
are divided into 2 treatment groupsLocations
1Anhui Provincial Cancer Hospital230001, HefeiAnhui, China
Sponsors and collaborators
Anhui Provincial Cancer Hospital
Lead sponsor
Source ClinicalTrials.gov