Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Antimetabolites

The patients will received Gemcitabine1000mg/m2(d1,d8)(iv)+carboplatin AUC 5 (d1)(iv),4 cycles, Sintilimab 200 mg (3mg/kg when the weight \<40kg ) (d1) (iv) in one cycle every 3 weeks, until PD or death.

Radiological examinations (according to the RECIST 1.1 criteria) at baseline will be repeated for tumor response evaluation following every two cycles of chemotherapy. Patients will be followed up to 30 days after the last dose of study chemotherapy, and then every 3 months.

Sintilimab combined with Gemcitabine and Carboplatin

Cheng zhi Zhou

Chengzhi Zhou, Professor

The trial was designed to explore the safety and efficacy of sintilimab combined with gemcitabine and carboplatin in the treatment of advanced LELC.

Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma

Exploratory Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma（LELC）

ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria

Safety will be assessed according to common terminology criteria for adverse events version 4.0 (CTC AE 4.0)

Each patient answers to specific questions in questionnaire The time frame of most questions is "How would you rate your quality fo life during the last month"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma	NCT04312204	Primary Pulmona... Lung Cancer	Sintilimab comb...	18 Years - 75 Years	Guangzhou Institute of Respiratory Disease
Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma	NCT04312204	Primary Pulmona... Lung Cancer	Sintilimab comb...	18 Years - 75 Years	Guangzhou Institute of Respiratory Disease

Spots Global Cancer Trial Database for sintilimab combined with gemcitabine and carboplatin