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

NCT ID: NCT06301828

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2026-02-21

Brief 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).

Conditions

Gastrointestinal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Envafolimab Injection

Intervention Type: DRUG

Endostar+SBRT+Envafolimab Injection

Endostar

Intervention Type: DRUG

Endostar+SBRT+Envafolimab Injection

Interventions

Envafolimab Injection

Endostar+SBRT+Envafolimab Injection

Intervention Type: DRUG

Endostar

Endostar+SBRT+Envafolimab Injection

Intervention Type: DRUG

Other Intervention Names

KN035; Recombinant Human Endostatin Injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

wei X wei, M.D.

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

wei x wei, M.D.

Role: CONTACT

gswxw@126.com

52271000 ext. 025

Facility Contacts

wei x wei, M.D.

Role: primary

52271000 ext. 025

Other Identifiers

KY202401

Identifier Type: -

Identifier Source: org_study_id