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Trial Title:
Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma
NCT ID:
NCT05687357
Condition:
Gastric Cancer
Gastroesophageal-junction Cancer
Conditions: Official terms:
Adenocarcinoma
Paclitaxel
Oxaliplatin
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
IV infusion
Arm group label:
Arm A: Tislelizumab + Chemoradiotherapy
Intervention type:
Drug
Intervention name:
S-1
Description:
Oral tablets
Arm group label:
Arm A: Tislelizumab + Chemoradiotherapy
Arm group label:
Arm B: Chemoradiotherapy
Arm group label:
Arm C: Chemotherapy
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
IV infusion
Arm group label:
Arm A: Tislelizumab + Chemoradiotherapy
Arm group label:
Arm B: Chemoradiotherapy
Arm group label:
Arm C: Chemotherapy
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
IV infusion
Arm group label:
Arm A: Tislelizumab + Chemoradiotherapy
Arm group label:
Arm B: Chemoradiotherapy
Arm group label:
Arm C: Chemotherapy
Intervention type:
Radiation
Intervention name:
Radiation
Description:
TOMO/VMAT
Arm group label:
Arm A: Tislelizumab + Chemoradiotherapy
Arm group label:
Arm B: Chemoradiotherapy
Summary:
The purpose of this study is to evaluate the efficacy of Tislelizumab in the neoadjuvant
(prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults
with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
The primary study hypotheses are that:
Neoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant
Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or
chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete
Response (pathCR) at the time of surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined by
T3~4aN+M0 or T4bNanyM0 （AJCC Version 8）
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
3. Has adequate organ function.
4. Male participants of childbearing potential must agree to use an adequate method of
contraception for the course of the study through 180 days after the last dose of
chemotherapy.
5. Female participants of childbearing potential must be willing to use an adequate
method of contraception for the course of the study through 180 days after the last
dose of chemotherapy or through 120 days after the last dose of pembrolizumab,
whichever is greater.
Exclusion Criteria:
1. Has a known additional malignancy that is progressing or has required active
treatment within the past 5 years. Note: Participants with basal cell carcinoma of
the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have
undergone potentially curative therapy are not excluded.
2. Has received prior systemic anti-cancer therapy including investigational agents for
the current malignancy.
3. Has an active infection requiring systemic therapy.
4. Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis.
5. Is currently participating in or has participated in a trial of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose
of study treatment.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 14 days prior the first dose of study treatment.
7. Has an active autoimmune disease that has required systemic treatment in past 2
years.
8. Has a known history of human immunodeficiency virus (HIV) infection.
9. Has a known history of Hepatitis B or known active Hepatitis C virus infection
(HBsAg positive with HBV DNA≥500 IU/ml；HCV：HCV antigen positive with HCV copies
>ULN).
10. Has had an allogenic tissue/solid organ transplant.
11. Has received a live vaccine within 30 days prior to the first dose of study
treatment.
12. Female participants who are breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Wuhan Tongji Hospital
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xianglin Yuan, MD
Facility:
Name:
Nanjing Drum Tower Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jia Wei, MD
Phone:
0086-025-83304616
Facility:
Name:
Shanxi Province Cancer Hospital
Address:
City:
Taiyuan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yusheng Wang, MD
Start date:
March 15, 2023
Completion date:
August 31, 2027
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687357
