Single-arm Phase II Clinical Study of Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma

Renmin Hospital of Wuhan University1 site in 1 country29 target enrollmentSeptember 26, 2022

ConditionsDisorder in Complete Remission in Response to Treatment

InterventionsSintilimal Injection

DrugsSintilimal Injection

Overview

Phase: Phase 2
Intervention: Sintilimal Injection
Conditions: Disorder in Complete Remission in Response to Treatment
Sponsor: Renmin Hospital of Wuhan University
Enrollment: 29
Locations: 1
Primary Endpoint: pathologic complete response (pCR) rate
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Prospective, Single-center, Single-arm, phase II clinical trial to explore the efficacy and safety of sintilimab (PD1 inhibitor) combined with XELOX chemotherapy, evaluate the pathological complete response rate of short-course radiotherapy combined with sintilimab and XELOX chemotherapy in neoadjuvant therapy for locally advanced gastric adenocarcinoma.

Registry

clinicaltrials.gov

Start Date

September 26, 2022

End Date

October 1, 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Renmin Hospital of Wuhan University

Responsible Party

Principal Investigator

Xiangpan Li

Professor

Renmin Hospital of Wuhan University

Eligibility Criteria

Inclusion Criteria

•All individuals recruited signed a written informed consent;
•Aged between 18 and 75 years;
•Histologically confirmed gastric adenocarcinoma, and Stage III (cT3-4aN1-3 M0, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cawas confirmed by enhanced CT/MRI scan (endoscopic ultrasonography (EUS) and laparoscopic exploration if necessary), and the lesion was resectable;
•No previous systemic therapy, including including surgery, radiotherapy, chemotherapy and immunotherapy, etc；
•Patients who have no contraindications and consent to radical surgery;
•Eastern Cooperative Group (ECOG) performance status score 0 or 1;
•Expected survival time \> 6 months;
•The main organ function of cases should be normal, and meet the following criteria: ①Absolute neutrophil count (ANC)≥1.5×109/L (no Granulocyte colony-stimulating factor within 14 days prior to enrolment); ②Platelets ≥100×109/L (no blood transfusion within 14 days prior to enrolment); ③Hemoglobin\>90g/L (no blood transfusion or no erythropoietin (EPO) dependence within 14 days prior to enrolment); ④Total bilirubin (TBIL) ≤1.5 x upper limit of normal (ULN), such as total bilirubin \> 1.5 x ULN but direct bilirubin ≤1.5 x ULN was also allowed to be enrolled; ⑤ALT (glutamic-pyruvic transaminase) and AST (glutamic-oxalacetic transaminase) ≤2.5 × ULN; ⑥Serum Cr≤1.5 × ULN and creatinine clearance ≥60 ml/min (Cockcroft-Gault formula); ⑦International normalized ratio (INR) \<1.5 or prothrombin time (PT)≤1.5 ULN; ⑧Thyroid stimulating hormone (TSH) was normal. If TSH was abnormal, subjects with total T3 (or FT3) and FT4 normal could also be enrolled; ⑨Myocardial infarction was normal.
•Female subjects of reproductive age must conduct pregnancy test (serum or urine) within 3 days before the first study drug administration (day 1 of cycle 1), and the results are negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as those who had been postmenopausal for at least 1 year or who had undergone surgical sterilization or hysterectomy;
•If there was a risk of conception, all subjects (male or female) were required to use contraception with an annual failure rate of less than 1% for the entire treatment period until 120 days after the last administration of the test drugs (or 180 days after the last administration of the chemotherapy drug ).

Exclusion Criteria

•Other malignancy disease history within five years, with the exception of basal cell carcinoma or squamous carcinoma of skin, and carcinoma in situ that have undergone radical resection;
•Endoscopic signs of active bleeding in the lesion;
•Is participating in an interventional clinical study or has received another study drug or used a study device within 4 weeks before the first study drug administration;
•Prior treatment with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. CTLA-4, OX40, CD137) drugs;
•Systemic systemic therapy with Chinese patent drugs or immunomodulatory agents (including thymosin, interferon, and interleukin, except for local use to control pleural effusion) with anti-tumor indications was received within 2 weeks before the first study drug administration;
•Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying agents, glucocorticoids, or immunosuppressants) occurred within 2 years before the first study drug administration. Replacement therapy (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;
•Had received systemic glucocorticoid therapy (excluding nasal, inhaled, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first study drug administration;
•Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
•Known allergy to drugs used in this study;
•Unable to intake Capecitabine orally (such as the inability to swallow and intestinal obstruction);

Arms & Interventions

Patients with untreated, operable locally advanced gastric adenocarcinoma

Drug: Sintilimal Injection Sintilimal (200mg) will be given i.v. on day 1 of each 3-week cycle. Drug: Capecitabine Capecitabine (1000mg/m2) will be administered orally twice daily on days 1-14 of each 3-week cycle. Drug: Oxaliplatin Oxaliplatin (130mg/m2) will be given i.v. on day 1 of each 3-week cycle.

Intervention: Sintilimal Injection