Gastric CancerPhase 2NCT05687357
Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma
A Phase 2 study testing Tislelizumab, S-1 and Oxaliplatin in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal-junction Cancer
- What is being tested?
- Tislelizumab, S-1 and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 3 sitesChina
- Study dates
- 15 Mar 2023to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Jia Wei, MD, 0086-025-83304616
- Not yet recruiting
Shanxi Province Cancer Hospital
Taiyuan, Shanxi
Yusheng Wang, MD
- Not yet recruiting
Wuhan Tongji Hospital
Wuhan, Hubei
Xianglin Yuan, MD
About this study
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
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
- Being tested
- Tislelizumab, S-1, Oxaliplatin, Nab paclitaxel, Radiation
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
IV infusion
S-1Drug
Oral tablets
OxaliplatinDrug
IV infusion
Nab paclitaxelDrug
IV infusion
RadiationRadiation
TOMO/VMAT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: S-1; Drug: Oxaliplatin; Drug: Nab paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 22 weeks
Secondary outcomes (2)
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.
Measured: Up to approximately 2 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start15 Mar 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687357
- Sponsor's protocol ID
- BGB-A317-2010-IIT
- Status last verified
- Oct 2022
- First submitted
- 26 Dec 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05687357
- Acronym / sponsor ID
- BGB-A317-2010-IIT
- Conditions
- Gastric Cancer, Gastroesophageal-junction Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Tislelizumab + Chemoradiotherapy | Experimental | Drug: Tislelizumab, Drug: S-1, Drug: Oxaliplatin, Drug: Nab paclitaxel, Radiation: RadiationNeoadjuvant: 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. |
| Arm B: Chemoradiotherapy | Active comparator | Drug: S-1, Drug: Oxaliplatin, Drug: Nab paclitaxel, Radiation: RadiationNeoadjuvant: 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. |
| Arm C: Chemotherapy | Active comparator | Drug: S-1, Drug: Oxaliplatin, Drug: Nab paclitaxelNeoadjuvant: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabIV infusion | Drug | Arm A: Tislelizumab + Chemoradiotherapy |
| S-1Oral tablets | Drug | Arm A: Tislelizumab + Chemoradiotherapy, Arm B: Chemoradiotherapy, Arm C: Chemotherapy |
| OxaliplatinIV infusion | Drug | Arm A: Tislelizumab + Chemoradiotherapy, Arm B: Chemoradiotherapy, Arm C: Chemotherapy |
| Nab paclitaxelIV infusion | Drug | Arm A: Tislelizumab + Chemoradiotherapy, Arm B: Chemoradiotherapy, Arm C: Chemotherapy |
| RadiationTOMO/VMAT | Radiation | Arm A: Tislelizumab + Chemoradiotherapy, Arm B: Chemoradiotherapy |
Primary outcome
Pathological Complete Response (pathCR) Rate
Time frame: Up to approximately 22 weeks
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.
2 secondary outcomes
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, S-1 and Oxaliplatin in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Wei, MD (0086-025-83304616, jiawei99@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pathCR) Rate (time frame: Up to approximately 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.