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

Phase 2

Recruiting

• Conditions: Gastrointestinal Neoplasms
• Interventions: Drug: Envafolimab Injection; Drug: Endostar

• Registration Number: NCT06301828
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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).

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-21
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Primary Completion: 2025-06-21
• Study Completion: 2026-02-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	Envafolimab Injection	Enrolled patients were treated with endostar combined with stereotactic body radiation therapy and Envafolimab.
Experimental group	Endostar	Enrolled patients were treated with endostar combined with stereotactic body radiation therapy and Envafolimab.

Primary Outcome Measures

Name	Time	Method
DCR	12 months after the last subject participating in	The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects
ORR	12 months after the last subject participating in	The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

Secondary Outcome Measures

Name	Time	Method
PFS	12 months after the last subject participating in	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.
Incidence of Treatment-Emergent Adverse Events	Up to 2 years	Occurrence and severity of AEs by NCI CTCAE v5.0

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China