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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

NCT06301828•Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 to 75 years old, regardless of gender
•advanced gastrointestinal tumors confirmed by histopathology or cytology;
•patients with gastrointestinal tumors who did not or refused standard treatment at enrollment；Each line of treatment for advanced disease includes one or more drugs for one or more cycles； The pre-permissible treatment was combined with molecular targeted drugs (except endostar)； Patients with previous PD-1 treatment were eligible
•ECOG-PS score of 0-2
•The main organ function was normal and met the following requirements: Blood routine examination (no blood transfusion within 14 days) : a. HB≥80g/L; b. ANC ≥1.5×109/L; c. PLT ≥60×109/L; ② Biochemical examination should meet the following criteria: a. BIL\<1.5 times the upper limit of normal (ULN); b. ALT and AST\<2.5×ULN; ALT and AST\< 5×ULN，if liver metastasis was present; c. Serum Cr≤1×ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula)
•predicted survival time ≥3 months
•Patients voluntarily participated in this study and signed the informed consent form (ICF)

Exclusion Criteria

•hypertensive patients whose blood pressure could not be reduced to normal range by antihypertensive drugs (systolic blood pressure\>140 mmHg/diastolic blood pressure \>90 mmHg); Patients with ≥ grade Ⅱ coronary artery disease, arrhythmia (including QTc prolongation \> 450 ms in men and \> 470 ms in women) and cardiac insufficiency
•patients with active immune diseases
•abnormal coagulation function (INR\>1.5×ULN, APTT\>1.5×ULN) with bleeding tendency
•symptomatic central nervous system metastasis
•pregnant or lactating women
•Other patients deemed ineligible for enrollment by the treating physician

Locations (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Key Dates

Start Date

February 21, 2024

Primary Completion Date

June 21, 2025

Completion Date

February 21, 2026

Last Updated

March 8, 2024

Enrollment

ESTIMATED participants

Conditions

Gastrointestinal Neoplasms

Interventions

Envafolimab Injection

DRUG

Endostar

DRUG

Contacts

wei x wei, M.D.

CONTACT

52271000 gswxw@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers

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