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

NCT05687357 | Recruiting Phase 2

• 1 other identifier: BGB-A317-2010-IIT
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gastric Cancer; Gastroesophageal-junction Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

Study Arms (3)

Arm A: Tislelizumab + Chemoradiotherapy

EXPERIMENTAL

Neoadjuvant: Prior to surgery, participants receive 4 cycles of Tislelizumab 200 mg via intravenous (IV) infusion on C1D1, C2D1, C2D22, C3D1 PLUS radiotherapy (TOMO or VMAT) 45Gy/1.5f PLUS S-1 initial dose depends on the body surface area, PO, bid, C1D1\~D14，C2D1\~C2D5, C2D8\~C2D12, C2D15\~C2D19, C2D22\~C2D26, C2D29\~C2D33, C3D1\~D14 and oxaliplatin 130mg/m\^2, IV, C1D1 and C3D1 OR S-1 initial dose depends on the body surface area, PO, bid, C1D1\~D14，C3D1\~D14 and nab-paclitaxel, IV 100\~120mg/m\^2，IV，C1D1，C1D8，C2D1，C2D8，C2D16，C2D22，C3D1 and C3D8. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of SOX OR S-1 and nab-paclitaxel AND 3 cycles of S-1, AND up to 16 cycles of Tislelizumab 200 mg via IV infusion on Day 1 Q3W.

Drug: Tislelizumab; Drug: S-1; Drug: Oxaliplatin; Drug: Nab paclitaxel; Radiation: Radiation

Arm B: Chemoradiotherapy

ACTIVE COMPARATOR

Neoadjuvant: Prior to surgery, participants receive radiotherapy (TOMO or VMAT) 45Gy/1.5f PLUS S-1 initial dose depends on the body surface area, PO, bid, C1D1\~D14，C2D1\~C2D5, C2D8\~C2D12, C2D15\~C2D19, C2D22\~C2D26, C2D29\~C2D33, C3D1\~D14 and oxaliplatin 130mg/m\^2, IV, C1D1 and C3D1 OR S-1 initial dose depends on the body surface area, PO, bid, C1D1\~D14，C3D1\~D14 and nab-paclitaxel, IV 100\~120mg/m\^2，IV，C1D1，C1D8，C2D1，C2D8，C2D16，C2D22，C3D1 and C3D8. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of SOX OR S-1 and nab-paclitaxel AND 3 cycles of S-1.

Drug: S-1; Drug: Oxaliplatin; Drug: Nab paclitaxel; Radiation: Radiation

Arm C: Chemotherapy

ACTIVE COMPARATOR

Neoadjuvant: S-1 initial dose depends on the body surface area, PO, bid, D1\~D14，Q 3W for 6 cycles, and oxaliplatin 130mg/m\^2, IV, D1 of each cycle for 6 cycles OR nab-paclitaxel, IV 100\~120mg/m\^2，IV，D1 and D8 for each cycle for 6 cycles. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of SOX OR S-1 and nab-paclitaxel AND 3 cycles of S-1.

Drug: S-1; Drug: Oxaliplatin; Drug: Nab paclitaxel

Interventions

Tislelizumab DRUG

IV infusion

Arm A: Tislelizumab + Chemoradiotherapy

S-1 DRUG

Oral tablets

Arm A: Tislelizumab + Chemoradiotherapy; Arm B: Chemoradiotherapy; Arm C: Chemotherapy

Oxaliplatin DRUG

IV infusion

Arm A: Tislelizumab + Chemoradiotherapy; Arm B: Chemoradiotherapy; Arm C: Chemotherapy

Nab paclitaxel DRUG

IV infusion

Arm A: Tislelizumab + Chemoradiotherapy; Arm B: Chemoradiotherapy; Arm C: Chemotherapy

Radiation RADIATION

TOMO/VMAT

Arm A: Tislelizumab + Chemoradiotherapy; Arm B: Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
• Has an active infection requiring systemic therapy.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
• 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 an active autoimmune disease that has required systemic treatment in past 2 years.
• Has a known history of human immunodeficiency virus (HIV) infection.
• 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).
• Has had an allogenic tissue/solid organ transplant.
• Has received a live vaccine within 30 days prior to the first dose of study treatment.
• Female participants who are breastfeeding.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (3)

Wuhan Tongji Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

tislelizumab; S 1 (combination); Oxaliplatin; Taxes; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Economics; Health Care Economics and Organizations; Physical Phenomena

Central Study Contacts

Jia Wei, MD

CONTACT

0086-025-83304616; jiawei99@nju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 18, 2023
• Study Start: March 15, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 19, 2023

Record last verified: 2022-10

Locations

CN (3)