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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Neoplasms
• Intervention / Treatment: Drug: Envafolimab Injection; Drug: Endostar

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 Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: wei x wei, M.D.; Phone Number: 025 52271000; Email: gswxw@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: wei x wei, M.D.; Phone Number: 025 52271000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Enrolled patients were treated with endostar combined with stereotactic body radiation therapy and Envafolimab.	Drug: Envafolimab Injection; Endostar+SBRT+Envafolimab Injection; Other Names: KN035; Drug: Endostar; Endostar+SBRT+Envafolimab Injection; Other Names: Recombinant Human Endostatin Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of Treatment-Emergent Adverse Events	Occurrence and severity of AEs by NCI CTCAE v5.0	Up to 2 years

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: wei X wei, M.D., The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): June 21, 2025
• Study Completion (Estimated): February 21, 2026

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostar protein; Endostatins
• Other Study ID Numbers: KY202401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No