Clinical trial NCT06301828: Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastrointestinal Neoplasms
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Gastrointestinal neoplasms
Primary purpose: TREATMENT

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.

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).

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

Primary outcomes:
measure: DCR
timeFrame: 12 months after the last subject participating in
measure: ORR
timeFrame: 12 months after the last subject participating in
Secondary outcomes:
measure: PFS
timeFrame: 12 months after the last subject participating in
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: wei X wei, M.D.
role: STUDY_DIRECTOR
References: