Treatment for advanced gastrointestinal tumors using Endostar, SBRT, and Envafolimab
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 study is testing a new treatment combining Endostar, radiation therapy, and Envafolimab to see if it helps people with advanced stomach or colon cancer who haven't had standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Drugs / interventions | Envafolimab, radiation, chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06301828 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and efficacy of a combination treatment involving Endostar, stereotactic body radiation therapy (SBRT), and Envafolimab in patients with advanced gastrointestinal tumors who have not received standard treatment. Sixteen patients with gastric or colorectal cancer, who either did not have access to or refused standard chemotherapy, will be enrolled. The study aims to assess the objective response rate and disease control rate as primary endpoints, while also monitoring safety, progression-free survival, and overall survival as secondary endpoints.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced gastrointestinal tumors who have not received or have refused standard treatment.
Not a fit: Patients with gastrointestinal tumors who are eligible for standard treatment or have a predicted survival time of less than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastrointestinal cancer who have limited treatment choices.
How similar studies have performed: While this approach is exploratory, similar combinations of targeted therapies and radiation have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: wei x wei, M.D.
- Email: gswxw@126.com
- Phone: 52271000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.