NCT05687357RecruitingPhase 2
Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma
Tislelizumab in Combination With Pre-operative Chemoradiotherapy Versus SOC for Patients With Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Multicenter, Randomized, Open-label, Phase IIB Trial
Source: ClinicalTrials.gov · Last updated 19 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 26 Dec 2022
- Start date
- 15 Mar 2023
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05687357
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 140
- From 15 Mar 2023 to the primary completion date, 28 Feb 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
- 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.
- 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.
- Has had an allogenic tissue/solid organ transplant.
- Has received a live vaccine within 30 days prior to the first dose of study treatment.
Other illness
- 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.
- Has an active infection requiring systemic therapy.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a known history of human immunodeficiency virus (HIV) infection.
Lab values
- 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).
Other
- Female participants who are breastfeeding.
Who the study is looking for
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3\~4aN+M0 or T4bNanyM0 （AJCC Version 8）
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
- Has adequate organ function.
- 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.
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Shanxi Province Cancer Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| Wuhan Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.