Clinical trial · Interventional
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
NCT06301828CI-TRIAL-00074882unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endostar | Drug | — | UNRESOLVED |
| Envafolimab Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Enrolled patients were treated with endostar combined with stereotactic body radiation therapy and Envafolimab.
- interventionNames
- Drug: Envafolimab Injection
- Drug: Endostar
Primary outcomes (2)
- measure
- DCR
- timeFrame
- 12 months after the last subject participating in
- description
- The proportion of subjects with complete response (CR), partial response (PR)and stable disease in(SD) in total subjects
- measure
- ORR
- timeFrame
- 12 months after the last subject participating in
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.