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

Launched by NANJING FIRST HOSPITAL, NANJING MEDICAL UNIVERSITY · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with advanced gastrointestinal cancer, which includes the use of a drug called Endostar, combined with a type of targeted radiation therapy known as stereotactic body radiation therapy (SBRT) and another medication called Envafolimab. The goal is to see how effective and safe this combination is for patients who have already received multiple treatments but may not have had success with standard options.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a confirmed diagnosis of advanced gastrointestinal tumors. They should have either not received standard treatment or have refused it. Additionally, their overall health should be stable, and their main organs should be functioning properly. Patients can expect close monitoring during the trial to assess how well the treatment works and to manage any side effects. This study is currently recruiting participants, so if you or a loved one meet the criteria and are interested, it could be an opportunity to explore a new treatment option.

Gender

ALL

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