Gastric CancerPhase 2NCT06238167
Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With LA GC/GEJC
A Phase 2 study testing Tislelizumab, S-1 therapy and low dose SOX therapy in people with Gastric Cancer, run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with tislelizumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or tegafur-gimeracil-oteracil potassium + oxaliplatin (SOX therapy) in PD-L1 CPS positive, elderly (≥70years old), pStage III… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Tislelizumab, S-1 therapy and low dose SOX therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Dec 2028
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with histologically confirmed adenocarcinoma of the stomach;
- Patients without a remnant cancer (R0) who have undergone gastrectomy within 6 weeks;
- According to the overall postoperative outcome, gastric cancer of stage III was determined according to the AJCC / UICC TNM Staging VII;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1;
- Patient with a confirmed pathological report related to the disease;
- No prior antitumor therapy (including immunotherapy, chemotherapy; radiotherapy), except for initial gastrectomy for primary lesions;
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- PD-L1 CPS (22C3) score ≥1 ;
- Hematological examination: no obvious signs of hematological diseases: neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥9 g/dL or ≥5.6 mmol/L, white blood cells ≥3.0×10^9/L, and no tendency to appear;Patients whose hematological indexes were at a critical value and could not meet the above criteria were determined by the researchers according to their physical conditions;
- Liver function test: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5×ULN, serum total bilirubin ≤1.5×ULN.For patients with Gilbert syndrome, serum total bilirubin < 3×ULN is required;
- Renal function test: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance > 60ml/min (calculated according to Cockcroft-Gault).
Who cannot join
- Treatment with any other investigational drug or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment;
- Postoperative complications that require clinical intervention and affect treatment, such as gastroparesis and dumping syndrome;
- Patients who are known to be allergic to or unable to tolerate the investigational drug;
- Uncontrolled serious medical conditions that the investigator believes will affect the subject's acceptance of the study protocol, such as co-existing serious medical conditions, including serious heart disease (such as New York Heart Association (NYHA) Class II or greater congestive heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infections, etc.
- Known active HIV infection : untreated active HBV (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center) and HCV infection (HCV antibody positive with HCV-RNA level higher than the lower limit of detection);
- Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
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- HBV viral load <1000 copies /ml(20IU/ml) prior to initial dosing, subjects should receive anti-HBV therapy throughout study drug treatment to avoid viral reactivation;
- For subjects with anti-HBC (+), HBsAg(-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required;
- Patients with malignant tumors other than gastric cancer (other than current gastric cancer) within the previous 5 years, patients will be eligible if all of the following criteria are met: treatment of malignant tumors for curative purposes, such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer after radical surgery (PSA≤10ng/ml);At the same time, according to the imaging follow-up results and any disease-specific tumor markers, no recurrence or metastasis was found.
- ≥ Grade 2 (according to CTC AE v5.0) dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, and perforation;
- Patients who were judged by the investigator to be unsuitable for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single Arm, Phase 2 Clinical Study Evaluating the Efficacy and Safety of Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The purpose of study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with tislelizumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or tegafur-gimeracil-oteracil potassium + oxaliplatin (SOX therapy) in PD-L1 CPS positive, elderly (≥70years old), pStage III gastric cancer (including esophagogastric junction cancer) after D2 dissection.
Read the detailed description
This is a prospective single-arm study to explore the safety and tolerability of chemotherapy combined with tislelizumab as postoperative adjuvant therapy in PD-L1 CPS positive, elderly, stage III gastric cancer/gastroesophageal junction adenocarcinoma.
Enrolled patients will receive chemotherapy combined with tislelizumab postoperative adjuvant therapy. Chemotherapy regimens were determined by the investigator as S-1 therapy or low dose SOX therapy:
S-1 therapy: S1 d1-14 bid (< 1.25m^ 40mg, 1.25m^2-1.5m2 50mg, ≥ 1.5m^2 60mg), followed by 7 days off (Q3W, max 16 cycles).
SOX treatment: oxaliplatin: 78mg/m2, d1, S-1: 50mg d1-14 bid, followed by 7 days off (Q3W, max 8 cycles).
Immunotherapy: Tislelizumab, 200mg Q3W, max 16 cycles.
The Primary endpoint is 1-year disease-free survival rate.
The secondary endpoints included:
- 2-year disease-free survival rate, 3-year disease-free survival rate.
- 2-year overall survival rate, 3-year overall survival rate.
- Median disease-free survival
- Median overall survival
- Safety
- Conditions
- Gastric Cancer
- Being tested
- Tislelizumab, S-1 therapy, low dose SOX therapy
- Keywords
- adjuvant therapy, elderly patients, tislelizumab, chemotherapy
- 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
Tislelizumab, 200mg Q3W, max 16 cycles.
S-1 therapyDrug
S1 d1-14 bid (< 1.25m^2 40mg, 1.25m^2-1.5m^2 50mg, ≥ 1.5m^2 60mg), followed by 7 days off (Q3W, max 16 cycles).
low dose SOX therapyDrug
Oxaliplatin: 78mg/m^2, d1, S-1: 50mg d1-14 bid, followed by 7 days off (Q3W, max 8 cycles).
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Treatment arm(Tislelizumab+S-1/SOX)
Enrolled patients will receive chemotherapy combined with tislelizumab postoperative adjuvant therapy. Chemotherapy regimens were determined by the investigator as S-1 therapy or low dose SOX therapy Receives: Drug: Tislelizumab; Drug: S-1 therapy; Drug: low dose SOX therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Disease-free survival rate
Measured: 1 year
Secondary outcomes (7)
2-year Disease-free survival rate
Measured: 2 years
3-year Disease-free survival rate
Measured: 3 years
2-year overall survival rate
Measured: 2 years
3-year overall survival rate
Measured: 3 years
DFS
Measured: 3 years
OS
Measured: 3 years
Safety will be analyzed through the incidence of adverse events, serious adverse events
Measured: Up to 28 days from last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (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 First Affiliated Hospital of Wenzhou Medical UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238167
- Sponsor's protocol ID
- Bailu-D2-01
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Phase 2 Clinical Study Evaluating the Efficacy and Safety of Tislelizumab Plus Chemotherapy as Postoperative Adjuvant Therapy in Elderly Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06238167
- Acronym / sponsor ID
- Bailu-D2-01
- Conditions
- Gastric Cancer
- Keywords
- adjuvant therapy, elderly patients, tislelizumab, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Feb 2024 (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 study is to evaluate the efficacy and safety of postoperative adjuvant chemotherapy with tislelizumab in combination with tegafur-gimeracil-oteracil potassium (S-1 therapy) or tegafur-gimeracil-oteracil potassium + oxaliplatin (SOX therapy) in PD-L1 CPS positive, elderly (≥70years old), pStage III gastric cancer (including esophagogastric junction cancer) after D2 dissection.
Detailed description
This is a prospective single-arm study to explore the safety and tolerability of chemotherapy combined with tislelizumab as postoperative adjuvant therapy in PD-L1 CPS positive, elderly, stage III gastric cancer/gastroesophageal junction adenocarcinoma.
Enrolled patients will receive chemotherapy combined with tislelizumab postoperative adjuvant therapy. Chemotherapy regimens were determined by the investigator as S-1 therapy or low dose SOX therapy:
S-1 therapy: S1 d1-14 bid (< 1.25m^ 40mg, 1.25m^2-1.5m2 50mg, ≥ 1.5m^2 60mg), followed by 7 days off (Q3W, max 16 cycles).
SOX treatment: oxaliplatin: 78mg/m2, d1, S-1: 50mg d1-14 bid, followed by 7 days off (Q3W, max 8 cycles).
Immunotherapy: Tislelizumab, 200mg Q3W, max 16 cycles.
The Primary endpoint is 1-year disease-free survival rate.
The secondary endpoints included:
- 2-year disease-free survival rate, 3-year disease-free survival rate.
- 2-year overall survival rate, 3-year overall survival rate.
- Median disease-free survival
- Median overall survival
- Safety
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Tislelizumab, Drug: S-1 therapy, Drug: low dose SOX therapyTreatment arm(Tislelizumab+S-1/SOX) Enrolled patients will receive chemotherapy combined with tislelizumab postoperative adjuvant therapy. Chemotherapy regimens were determined by the investigator as S-1 therapy or low dose SOX therapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed adenocarcinoma of the stomach;
- Patients without a remnant cancer (R0) who have undergone gastrectomy within 6 weeks;
- According to the overall postoperative outcome, gastric cancer of stage III was determined according to the AJCC / UICC TNM Staging VII;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1;
- Patient with a confirmed pathological report related to the disease;
Key exclusion criteria (11 listed)
- Treatment with any other investigational drug or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment;
- Postoperative complications that require clinical intervention and affect treatment, such as gastroparesis and dumping syndrome;
- Patients who are known to be allergic to or unable to tolerate the investigational drug;
- Uncontrolled serious medical conditions that the investigator believes will affect the subject's acceptance of the study protocol, such as co-existing serious medical conditions, including serious heart disease (such as New York Heart Association (NYHA) Class II or greater congestive heart failure), cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infections, etc.
- Known active HIV infection : untreated active HBV (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center) and HCV infection (HCV antibody positive with HCV-RNA level higher than the lower limit of detection);
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 |
|---|---|---|
| TislelizumabTislelizumab, 200mg Q3W, max 16 cycles. | Drug | Arm A |
| S-1 therapyS1 d1-14 bid (< 1.25m^2 40mg, 1.25m^2-1.5m^2 50mg, ≥ 1.5m^2 60mg), followed by 7 days off (Q3W, max 16 cycles). | Drug | Arm A |
| low dose SOX therapyOxaliplatin: 78mg/m^2, d1, S-1: 50mg d1-14 bid, followed by 7 days off (Q3W, max 8 cycles). | Drug | Arm A |
Primary outcome
1-year Disease-free survival rate
Time frame: 1 year
7 secondary outcomes
2-year Disease-free survival rate
Time frame: 2 years
3-year Disease-free survival rate
Time frame: 3 years
2-year overall survival rate
Time frame: 2 years
3-year overall survival rate
Time frame: 3 years
DFS
Time frame: 3 years
OS
Time frame: 3 years
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time frame: Up to 28 days from last dose
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 2 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, S-1 therapy and low dose SOX therapy in people with Gastric Cancer, run by First Affiliated Hospital of Wenzhou Medical University.
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 10 inclusion and 11 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: opening soon, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Jun Cheng (86-13600668439, 1043475708@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Disease-free survival rate (time frame: 1 year). 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 2 Feb 2024.