Gastric CancerPhase 2NCT06374901
Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment.
A Phase 2 study testing Tislelizumab and SOX/XELOX in people with Gastric Cancer, run by Xiangdong Cheng at 1 site in China.
Trial summary
To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Tislelizumab and SOX/XELOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2024to 31 Mar 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient voluntarily joined this study and signed an informed consent form;
- Age ≥ 18 years old, ≤ 75 years old
- Pathological diagnosis of gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction
- Patients must be able to provide fresh slices of tumor tissue (FFPE tissue blocks or approximately 15 slides), unstained FFPE slides, and if clinically feasible, fresh biopsy samples will be preferred. If archived samples cannot be obtained, fresh tumor biopsy specimens must be collected during the baseline period, with the same requirements for glass slides as archived tumor tissue
- Clinical staging determined by CT and laparoscopy for curative resection is cT3~4aN+M0 or cT4bNanyM0 for gastric and gastroesophageal junction adenocarcinoma patients (according to AJCC 8th edition staging)
- Have not received anti-tumor treatment (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)
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- Plan to undergo surgical treatment after the completion of neoadjuvant therapy
- Able to swallow pills normally
- ECOG score 0-1 points
- Expected survival time ≥ 12 months
- Normal function of major organs, i.e. meeting the following criteria:The standard for blood routine examination must comply with: (No blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors)，Neutrophil absolute count ≥ 1.5 × 109/L; Platelets ≥ 80 × 109/L; Hemoglobin ≥ 80g/L
- Biochemical examination must meet the following standards: Total bilirubin<1.5
- ULN; ALT and AST ≤ 2.5 × ULN; Serum Cr ≤ 1.5 x ULN or endogenous creatinine clearance rate>50ml/min (male: endogenous creatinine clearance rate=(140 age) x body weight)/(72 x serum Cr); Female: Endogenous creatinine clearance rate=(140 age) x body weight/(72 x serum Cr) x 0.85; Weight unit: kg; Serum Cr unit: mg/mL
- Female subjects with pregnancy ability must undergo a serum pregnancy test within 7 days before the first medication, and the result is negative. They are willing to use efficient contraception methods during the trial period and 120 days after the last dose. For male subjects whose partners are women of childbearing age, surgical sterilization or agreement to use efficient methods of contraception during the trial period and 120 days after the last dose should be considered
Who cannot join
- There are non resectable factors, including tumor reasons that cannot be resected or surgical contraindications that cannot be resected or those who refuse surgery
- Previously or currently suffering from other malignant tumors
- Suffering from any chronic or major illness that is considered intolerable to treatment (such as severe heart disease, uncontrolled hypertension, certain degrees of liver and kidney dysfunction, etc.)
- Those who have experienced gastrointestinal perforation, abdominal abscess in the past, or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms indicating accompanying intestinal obstruction
- If there are significant clinically significant bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, within the first 3 months prior to the first use of the study drug, and if fecal occult blood is positive during the baseline period, a follow-up examination can be conducted. If the results are still positive after the follow- up examination, a gastroscopy examination is required (excluding those who have undergone gastroscopy examination within 3 months prior to enrollment to exclude such situations)
- If the patient is in the active infection stage and needs treatment (such as using antibiotics, antiviral drugs, or antifungal drugs)
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- Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV copy number>upper limit of normal value)
- Patients with congenital or acquired immune dysfunction (such as HIV infected individuals)
- Patients with any active autoimmune diseases or a history of autoimmune diseases with the possibility of recurrence
- Planned or previously received organ or allogeneic bone marrow transplantation
- Subjects who currently have interstitial pneumonia or interstitial lung disease, or have a history of requiring hormone therapy for interstitial pneumonia or interstitial lung disease, or those whose screening period CT shows active pneumonia or severe lung function impairment; Active pulmonary tuberculosis
- Current or recent use of immunosuppressive drugs or systemic corticosteroids for the purpose of achieving immunosuppression
- Patients who have received attenuated live vaccines within 28 days prior to the first use of the study drug, or who need to receive such vaccines during treatment or within 60 days after the last dose
- Known to be allergic to any investigational drug or excipient
- Lactating women
- Any factors determined by the researcher that may affect patient safety and result in the forced termination of this study midway
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang
About this study
Official title: A Multicenter, Prospective Phase II Clinical Study of Tislelizumab in Combination With Chemotherapy for the Perioperative Treatment of Resectable Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR).
Read the detailed description
This study is a multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of Tislelizumab combined with chemotherapy in the perioperative treatment of resectable locally advanced gastric and gastroesophageal junction adenocarcinoma.
A study aimed at untreated gastric and gastroesophageal junction adenocarcinoma patients with resectable locally advanced cT3~4aN+M0 or cT4bNanyM0 (according to AJCC 8th edition staging) The study aimed to enroll 134 untreated resectable locally advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma patients, with the primary pathological response rate (MPR) as the primary endpoint.
The subjects need to undergo a screening period examination within 21 days before randomization to determine whether they meet the study conditions. Subjects who meet the research criteria will be randomly divided into MHC - Ⅱ positive group (IHC ≥ 2+) and MHC - Ⅱ negative group (IHC 0/1+) based on their MHC - Ⅱ expression. The MHC - Ⅱ positive group (IHC ≥ 2+) will be randomly divided into two groups in a 1:1 ratio, receiving either Tislelizumab combined with chemotherapy (Group A) or chemotherapy (Group B). The MHC - Ⅱ negative group (IHC 0/1+) will be randomly divided into two groups in a 1:1 ratio, receiving either Tislelizumab combined with chemotherapy (Group C) or chemotherapy (Group D). Randomly stratified factors include Lauren classification (intestinal type vs. diffuse type vs. mixed type).
Based on the sample size assumption of this study, the proportion of MHC - Ⅱ positive population in this study should reach at least 50%.
- Conditions
- Gastric Cancer
- Being tested
- Tislelizumab, SOX/XELOX
- 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
Preoperative treatment with Tislelizumab
SOX/XELOXDrug
Preoperative treatment with SOX/XELOX
| Study group | Role | What they receive |
|---|---|---|
| A (MHC-II positive with Tislelizumab and SOX/XELOX) | Experimental | Preoperative treatment with Tislelizumab and SOX/XELOX for MHC-II positive patient. Receives: Drug: Tislelizumab; Drug: SOX/XELOX |
| B (MHC-II positive with SOX/XELOX) | Active comparator | Preoperative treatment with SOX/XELOX for MHC-II positive patient. Receives: Drug: SOX/XELOX |
| C (MHC-II negative with Tislelizumab and SOX/XELOX) | Experimental | Preoperative treatment with Tislelizumab and SOX/XELOX for MHC-II negative patient. Receives: Drug: Tislelizumab; Drug: SOX/XELOX |
| D (MHC-II negative with SOX/XELOX) | Active comparator | Preoperative treatment with SOX/XELOX for MHC-II negative patient. Receives: Drug: SOX/XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRP (Main pathological response)
The percentage of subjects who showed no residual tumor cells (including lymph nodes, stage ypT0N0M0) and only residual single or small focal cancer cells under the light microscope
Measured: After operation about 2 weeks until postoperative pathology report come out.
Secondary outcomes (3)
pCR (pathologic complete response)
The percentage of subjects with a TRG grade of 0 who do not have live tumor cell residues in the primary tumor lesion
Measured: After operation about 2 weeks until postoperative pathology report come out.
DFS (Disease free survival)
Refers to the time between the time of baseline imaging evaluation and disease recurrence or death (whichever occurs first) in disease-free subjects after surgery.
Measured: From date of randomization until the date of first documented progression， assessed up to 100 months
OS (Overall survival)
The time between the date of enrollment and death from any cause
Measured: From date of randomization until the date of death, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start25 Apr 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 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.
- 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
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangdong Cheng
- Sponsor type
- University, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, Shanxi Province Cancer Hospital, Sichuan Cancer Hospital and Research Institute, The Second Affiliated Hospital of Harbin Medical University
- Responsible party
- Sponsor-investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
- Investigators
- Xiangdong Cheng, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374901
- Sponsor's protocol ID
- IRB-2024-311
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Phase II Clinical Study of Tislelizumab in Combination With Chemotherapy for the Perioperative Treatment of Resectable Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06374901
- Acronym / sponsor ID
- IRB-2024-311
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Xiangdong ChengUniversity, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, Shanxi Province Cancer Hospital, Sichuan Cancer Hospital and Research Institute, The Second Affiliated Hospital of Harbin Medical University
- Study start
- 25 Apr 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 19 Apr 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.
To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR).
Detailed description
This study is a multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of Tislelizumab combined with chemotherapy in the perioperative treatment of resectable locally advanced gastric and gastroesophageal junction adenocarcinoma.
A study aimed at untreated gastric and gastroesophageal junction adenocarcinoma patients with resectable locally advanced cT3~4aN+M0 or cT4bNanyM0 (according to AJCC 8th edition staging) The study aimed to enroll 134 untreated resectable locally advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma patients, with the primary pathological response rate (MPR) as the primary endpoint.
The subjects need to undergo a screening period examination within 21 days before randomization to determine whether they meet the study conditions. Subjects who meet the research criteria will be randomly divided into MHC - Ⅱ positive group (IHC ≥ 2+) and MHC - Ⅱ negative group (IHC 0/1+) based on their MHC - Ⅱ expression. The MHC - Ⅱ positive group (IHC ≥ 2+) will be randomly divided into two groups in a 1:1 ratio, receiving either Tislelizumab combined with chemotherapy (Group A) or chemotherapy (Group B). The MHC - Ⅱ negative group (IHC 0/1+) will be randomly divided into two groups in a 1:1 ratio, receiving either Tislelizumab combined with chemotherapy (Group C) or chemotherapy (Group D). Randomly stratified factors include Lauren classification (intestinal type vs. diffuse type vs. mixed type).
Based on the sample size assumption of this study, the proportion of MHC - Ⅱ positive population in this study should reach at least 50%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A (MHC-II positive with Tislelizumab and SOX/XELOX) | Experimental | Drug: Tislelizumab, Drug: SOX/XELOXPreoperative treatment with Tislelizumab and SOX/XELOX for MHC-II positive patient. |
| B (MHC-II positive with SOX/XELOX) | Active comparator | Drug: SOX/XELOXPreoperative treatment with SOX/XELOX for MHC-II positive patient. |
| C (MHC-II negative with Tislelizumab and SOX/XELOX) | Experimental | Drug: Tislelizumab, Drug: SOX/XELOXPreoperative treatment with Tislelizumab and SOX/XELOX for MHC-II negative patient. |
| D (MHC-II negative with SOX/XELOX) | Active comparator | Drug: SOX/XELOXPreoperative treatment with SOX/XELOX for MHC-II negative patient. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The patient voluntarily joined this study and signed an informed consent form;
- Age ≥ 18 years old, ≤ 75 years old
- Pathological diagnosis of gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction
- Patients must be able to provide fresh slices of tumor tissue (FFPE tissue blocks or approximately 15 slides), unstained FFPE slides, and if clinically feasible, fresh biopsy samples will be preferred. If archived samples cannot be obtained, fresh tumor biopsy specimens must be collected during the baseline period, with the same requirements for glass slides as archived tumor tissue
- Clinical staging determined by CT and laparoscopy for curative resection is cT3~4aN+M0 or cT4bNanyM0 for gastric and gastroesophageal junction adenocarcinoma patients (according to AJCC 8th edition staging)
Key exclusion criteria (16 listed)
- There are non resectable factors, including tumor reasons that cannot be resected or surgical contraindications that cannot be resected or those who refuse surgery
- Previously or currently suffering from other malignant tumors
- Suffering from any chronic or major illness that is considered intolerable to treatment (such as severe heart disease, uncontrolled hypertension, certain degrees of liver and kidney dysfunction, etc.)
- Those who have experienced gastrointestinal perforation, abdominal abscess in the past, or recent (within 3 months) intestinal obstruction or imaging and clinical symptoms indicating accompanying intestinal obstruction
- If there are significant clinically significant bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis, within the first 3 months prior to the first use of the study drug, and if fecal occult blood is positive during the baseline period, a follow-up examination can be conducted. If the results are still positive after the follow- up examination, a gastroscopy examination is required (excluding those who have undergone gastroscopy examination within 3 months prior to enrollment to exclude such situations)
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 |
|---|---|---|
| TislelizumabPreoperative treatment with Tislelizumab | Drug | A (MHC-II positive with Tislelizumab and SOX/XELOX), C (MHC-II negative with Tislelizumab and SOX/XELOX) |
| SOX/XELOXPreoperative treatment with SOX/XELOX | Drug | A (MHC-II positive with Tislelizumab and SOX/XELOX), B (MHC-II positive with SOX/XELOX), C (MHC-II negative with Tislelizumab and SOX/XELOX), D (MHC-II negative with SOX/XELOX) |
Primary outcome
MRP (Main pathological response)
Time frame: After operation about 2 weeks until postoperative pathology report come out.
The percentage of subjects who showed no residual tumor cells (including lymph nodes, stage ypT0N0M0) and only residual single or small focal cancer cells under the light microscope
3 secondary outcomes
pCR (pathologic complete response)
Time frame: After operation about 2 weeks until postoperative pathology report come out.
DFS (Disease free survival)
Time frame: From date of randomization until the date of first documented progression， assessed up to 100 months
OS (Overall survival)
Time frame: From date of randomization until the date of death, assessed up to 120 months
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 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.
Xiangdong Cheng study chair
Zhejiang Cancer Hospital
1 site 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 and SOX/XELOX in people with Gastric Cancer, run by Xiangdong Cheng at 1 site 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 14 inclusion and 16 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Xiangdong Cheng (13968032995, chengxd@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRP (Main pathological response) (time frame: After operation about 2 weeks until postoperative pathology report come out.). 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 2024.