Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687357
• Other study ID #: BGB-A317-2010-IIT
• Status: Recruiting
• Phase: Phase 2
• Start date: March 15, 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: October 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Jia Wei, MD
• Phone: 0086-025-83304616
• Email: jiawei99[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 31, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Cancer
• Gastroesophageal-junction Cancer

Intervention

Drug:
• Tislelizumab
IV infusion
• S-1
Oral tablets
• Oxaliplatin
IV infusion
• Nab paclitaxel
IV infusion

Radiation:
• Radiation
TOMO/VMAT

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Shanxi Province Cancer Hospital	Taiyuan	Shanxi
China	Wuhan Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response (pathCR) Rate	PathCR rate is defined as the percentage of participants having a pathCR. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.	Up to approximately 22 weeks
Secondary	Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	EFS is based on RECIST 1.1 as assessed by the investigator and is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by CT scan or biopsy if indicated (for participants who are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), are not considered EFS events.	Up to approximately 2 years
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 2 years