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Trial Title:
Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors
NCT ID:
NCT06301828
Condition:
Gastrointestinal Neoplasms
Conditions: Official terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Endostar protein
Endostatins
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Gastrointestinal neoplasms
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Envafolimab Injection
Description:
Endostar+SBRT+Envafolimab Injection
Arm group label:
Experimental group
Other name:
KN035
Intervention type:
Drug
Intervention name:
Endostar
Description:
Endostar+SBRT+Envafolimab Injection
Arm group label:
Experimental group
Other name:
Recombinant Human Endostatin Injection
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanjing First Hospital
Address:
City:
Nanjing
Zip:
210006
Country:
China
Status:
Recruiting
Contact:
Last name:
wei x wei, M.D.
Phone:
52271000
Phone ext:
025
Start date:
February 21, 2024
Completion date:
February 21, 2026
Lead sponsor:
Agency:
Nanjing First Hospital, Nanjing Medical University
Agency class:
Other
Source:
Nanjing First Hospital, Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06301828
