To evaluate the Efficacy and Safety of the Combination of Sintilimab With Platinum-doublet Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients
The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study
Age range of 18-75 years old upon enrollment, both male and female are eligible
Stage III NSCLC confirmed by histology or cytology (according to the International Union Against Cancer and the Joint American Committee on Cancer 8th edition TNM staging of lung cancer)
It was clarified that surgical resection is not possible After MDT discussion,
There are any small cell carcinoma components present in the histopathology, as well as special types such as salivary gland type and SMARCA4 deficiency
Except for NSCLC, the subjects had other malignant tumors within the 5 years prior to enrollment. Subjects with other tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ, are not excluded
Previously received local treatments for tumor lesions such as thoracic radiotherapy and radiofrequency ablation
Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used to treat thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications within 1 week before the first administration
Single group
Experimental
DrugDrug: Sintilimab, 200mg IV D1 Q3W, Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5 D1 IV Q3W, Paclitaxel or Paclitaxel liposome 135-175mg/m2 D1 IV Q3W(Squamous） Drug: Sintilimab, 200mg IV D1 Q3W, Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5 D1 IV Q3W, Pemetrexed, 500mg/m2 D1 IV Q3W(adenocarcinoma） Radiation:Adaptive radiotherapy with V20\<20%: 1.PGTV60-66Gy/2.0-2.2Gy/30F;PTV54Gy/1.8Gy/30F;2.PGTV54-66Gy/2.0-2.2Gy/30F；3.PGTV50Gy/2.0Gy/25F
Progression-Free Survival (PFS)
The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause
Objective Response Rate (ORR)
the rate of patients with PR and CR
Disease Control Rate (DCR)
the rate of patients with PR and CR and SD
Overall Survival (OS)
The time from the beginning of treatment to the time when the patient dies from any cause
Duration of response (DoR)
Duration of Response (DoR) is defined as the time from the date of first documented objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the date of first documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the date of their last adequate tumor assessment.
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