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

Nanjing Medical University

Status and phase

Enrolling

Phase 2

Conditions

Gastrointestinal Neoplasms

Treatments

Drug: Envafolimab Injection

Drug: Endostar

Study type

Interventional

Funder types

Other

Identifiers

NCT06301828

KY202401

Details and patient eligibility

About

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.

Full 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).

Enrollment

16 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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