Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Local injection of Envafolimab 5mg/kg plus platinum-based chemotherapy under fiberoptic bronchoscopy, Q2W.

Envafolimab Injection

xu x xiang, Doctor

xu X xiang, Doctor

The aim of this single-arm, exploratory clinical study is to evaluate the safety and efficacy of local injection of envafolimab combined with chemotherapy in the first-line treatment of non-small cell lung cancer (NSCLC) patients, and to observe the changes of immune cells in the local immune microenvironment before and after immunotherapy, in order to find new indicators for immunotherapy evaluation.

In this study, 16 patients with NSCLC were enrolled to explore the clinical effect of chemotherapy combined with local injection of Envafolimab. To determine whether the treatment of metastatic/recurrent NSCLC with Envafolimab is effective, and whether the treatment of Envafolimab combined with chemotherapy can prolong the PFS\\OS of patients with NSCLC, and to screen for a more effective treatment mode for Chinese NSCLC patients.

A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer

A Single-arm, Exploratory Clinical Trial Investigating the Efficacy of Local Envafolimab Injection Under Fiberoptic Bronchoscopy Combined With Chemotherapy in Non-small Cell Lung Cancer

OS is defined as the time from randomization to death due to any cause.

ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1

Progression free survival (PFS) is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).

DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.

DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.

The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

Northern Jiangsu People's Hospital

Director

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Endostar protein

Endostatins

Angiogenesis Inhibitors

Growth Inhibitors

Enrolled patients were treated with endostar combined with stereotactic body radiation therapy and Envafolimab.

Endostar

wei x wei, M.D.

wei X wei, M.D.

This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment.

This is a single-arm, prospective and exploratory clinical study. Sixteen patients with gastric or colorectal cancer who did not have standard treatment or refused standard treatment/chemotherapy after multi-line treatment were enrolled. The patients were treated with endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab to evaluate the efficacy and safety of this regimen. The primary endpoints were objective response rate (ORR) and disease control rate (DCR). The secondary endpoints were safety, progression-free survival (PFS) and overall survival (OS).

Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors

A Prospective, Single-arm Clinical Study of Endostar Combined With Stereotactic Body Radiation Therapy and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors After Multi-line Treatment

The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects

The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

Progression-free survival (PFS per RECIST 1.1) is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.

Occurrence and severity of AEs by NCI CTCAE v5.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer	NCT06108726	NSCLC	Envafolimab Inj...	18 Years -	Northern Jiangsu People's Hospital
Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors	NCT06301828	Gastrointestina...	Envafolimab Inj... Endostar	18 Years - 75 Years	Nanjing First Hospital, Nanjing Medical University
A Study of Local Envafolimab Injection Combined With Chemotherapy in Non-small Cell Lung Cancer	NCT06108726	NSCLC	Envafolimab Inj...	18 Years -	Northern Jiangsu People's Hospital

Spots Global Cancer Trial Database for envafolimab injection