Actively Recruiting
Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2023-04-19
140
Participants Needed
3
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated localized gastric or gastroesophageal junction adenocarcinoma classified as T3~4aN+M0 or T4bNanyM0 (AJCC Version 8)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ function
- Male participants of childbearing potential agree to use effective contraception during the study and for 180 days after last chemotherapy dose
- Female participants of childbearing potential agree to use effective contraception during the study and for at least 180 days after last chemotherapy dose or 120 days after last pembrolizumab dose, whichever is longer
You will not qualify if you...
- Known additional progressing malignancy or requiring treatment within past 5 years, except basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ treated curatively
- Prior systemic anti-cancer therapy including investigational agents for current cancer
- Active infection needing systemic therapy
- History of pneumonitis requiring steroids or current pneumonitis
- Participation in investigational agent or device trial within 4 weeks before study treatment
- Diagnosis of immunodeficiency or use of systemic steroids over 10 mg prednisone equivalent daily or other immunosuppressive therapy within 14 days before study treatment
- Active autoimmune disease requiring systemic treatment in past 2 years
- Known HIV infection
- Known Hepatitis B or active Hepatitis C infection
- History of allogenic tissue or organ transplant
- Receipt of live vaccine within 30 days before study treatment
- Female participants who are breastfeeding
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Wuhan Tongji Hospital
Wuhan, Hubei, China
Not Yet Recruiting
2
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
3
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
Research Team
J
Jia Wei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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