Tirelizumab in Combination With Chemoradiation in Patients With Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Trial Title: Tirelizumab in Combination With Chemoradiation in Patients With Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

NCT ID: NCT05528367

Condition: Locally Advanced Gastric Cancer

Conditions: Official terms:
Adenocarcinoma
Stomach Neoplasms

Conditions: Keywords:
chemoradiotherapy
tirelizumab

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Nab-PTX,S-1,Tirelizumab
Description: S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 =1.5 m2 ,120 mg daily. Nab-PTX:130mg/m2,d1，8，q3w；100mg qw(during radiation) Tirelizumab：200mg d1 q3w.
Arm group label: CRT with Tirelizumab

Intervention type: Radiation
Intervention name: Chemoradiation
Description: 45-50Gy/25F
Arm group label: CRT with Tirelizumab

Summary: To evaluate the efficacy and safety of chemoradiotherapy combined with tirelizumab in the treatment of initial unresectable locally advanced gastric cancer or gastroesophageal junction cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Male or female patients, aged ≥ 18 years; ≤ 75 years old; 2. The histopathology confirmed the diagnosis of previously untreated locally advanced unresectable HER2 negative gastric or gastroesophageal junction adenocarcinoma (imaging evaluation showed that the primary tumor was severely invaded, could not be separated from the surrounding normal tissue, or had surrounded large blood vessels, or regional lymph nodes were fixed and fused, or the metastatic lymph nodes were not within the scope of surgical clearance), and there was no peritoneal metastasis during laparoscopic exploration; 3. There is no serious liver and kidney function damage, and the functional level of organs must meet the following requirements: ANC ≥ 1.5 × 109/L； PLT ≥ 90 × 109/L； Hb ≥ 90 g/L； TBIL ≤ 1 × ULN； ALT and AST ≤ 1.5 × ULN，ALP ≤ 2.5 × ULN； Bun and Cr ≤ 1 × ULN and creatinine clearance ≥ 50 ml / min (Cockcroft Gault formula); LVEF ≥ 50%； The QT interval (QTCF) corrected by fridericia method was < 450 ms in males and < 470 MS in females; INR ≤ 1.5 × ULN，APTT ≤ 1.5 × ULN； 4. The patient has at least one measurable lesion, which is evaluated by the investigator according to (RECIST) v1.1; 5. ECoG PS score 0 or 1; 6. Life expectancy ≥ 6 months; 7. The investigator assessed that the patient could comply with the protocol requirements; 8. Sign the informed consent document. Exclusion Criteria: 1. Received systemic cytotoxic drug chemotherapy; 2. Patients with hypersensitivity or hypersensitivity to therapeutic drugs and patients with autoimmune diseases; Have received allogeneic tissue / solid organ transplantation; 3. There is third space effusion (such as pleural fluid and ascites) that cannot be controlled by drainage or other methods; 4. Use steroids for more than 50 days, or need to use steroids for a long time; 5. Uncontrolled symptomatic brain metastases or mental disorders cannot correctly express subjective symptoms; 6. The abnormal coagulation function has clinical significance, has bleeding tendency or is receiving thrombolytic or anticoagulant treatment; 7. Unable to swallow, chronic diarrhea and intestinal obstruction, and there are many factors affecting drug taking and absorption; 8. Other malignant tumors occurred within 5 years before enrollment, except for cervical carcinoma in situ or skin squamous or basal cell carcinoma that had been treated for radical cure before; 9. Pregnant or lactating women who have fertility but refuse to take contraceptive measures; 10. Those with serious heart disease or medical history, including: recorded history of congestive heart failure, high-risk uncontrollable arrhythmia, angina pectoris requiring medical treatment, clinically clear heart valve disease, history of serious myocardial infarction and stubborn hypertension; 11. According to the judgment of the investigator, there are concomitant diseases (such as uncontrolled hypertension, diabetes, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study; 12. The investigator determines that other conditions are not suitable for inclusion in the study.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Liu luying

Address:
City: Hangzhou
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: Liu Lu ying, MD

Phone: 571-88128142

Phone ext: +86
Email: luyingliu@163.com

Start date: January 1, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Zhejiang Cancer Hospital
Agency class: Other

Source: Zhejiang Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05528367