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

Gastrointestinal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301828
• Other study ID #: KY202401
• Status: Recruiting
• Phase: Phase 2
• Start date: February 21, 2024
• Est. completion date: February 21, 2026

Study information

• Verified date: February 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: wei x wei, M.D.
• Phone: 52271000
• Email: gswxw[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: February 21, 2026
• Est. primary completion date: June 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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; ? 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 ? 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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

Drug:
• Envafolimab Injection
Endostar+SBRT+Envafolimab Injection
• Endostar
Endostar+SBRT+Envafolimab Injection

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DCR	The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects	12 months after the last subject participating in
Primary	ORR	The proportion of subjects with complete response (CR) and partial response (PR) in total subjects	12 months after the last subject participating in
Secondary	PFS	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.	12 months after the last subject participating in
Secondary	Incidence of Treatment-Emergent Adverse Events	Occurrence and severity of AEs by NCI CTCAE v5.0	Up to 2 years