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

Locally Advanced Gastric Cancer Clinical Trial

Official title:

Tirelizumab in Combination With Chemoradiation in Patients With Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma：A Single Arm Phase II Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528367
• Other study ID #: ZhejiangCH20211029
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2021
• Source: Zhejiang Cancer Hospital
• Contact: Liu Lu ying, MD
• Phone: 0571-88128142
• Email: luyingliu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Locally Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Nab-PTX,S-1,Tirelizumab
S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily. Nab-PTX:130mg/m2,d1,8,q3w;100mg qw(during radiation) Tirelizumab:200mg d1 q3w.

Radiation:
• Chemoradiation
45-50Gy/25F

Locations

Country	Name	City	State
China	Liu luying	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of resectable patients with negative incisal margin R0 resection rate	the rate of resectable patients with negative incisal margin	18 weeks after treatment completion