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

NCT06301828 | Recruiting Phase 2

• 1 other identifier: KY202401
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• PFS

  12 months after the last subject participating in

• Incidence of Treatment-Emergent Adverse Events

  Up to 2 years

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Drug: Envafolimab Injection; Drug: Endostar

Interventions

Envafolimab Injection DRUG

Endostar+SBRT+Envafolimab Injection

Also known as: KN035

Experimental group

Endostar DRUG

Endostar+SBRT+Envafolimab Injection

Also known as: Recombinant Human Endostatin Injection

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

envafolimab; endostar protein; Endostatins

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• wei X wei, M.D.

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

wei x wei, M.D.

CONTACT

52271000; gswxw@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Gastrointestinal neoplasms

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: February 21, 2024
• Primary Completion: June 21, 2025
• Study Completion: February 21, 2026
• Last Updated: March 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)