Liver MetastasesPhase 2/3NCT05325528
Study of Tislelizumab in Combination With SOX for the Treatment of Gastric Cancer With Liver Metastases
A Phase 2/3 study testing Tislelizumab in Combination with Oxaliplatin and Tegafur in people with Liver Metastases, run by Zhejiang University at 1 site in China.
Trial summary
Liver metastases are one of the most common sites of metastasis in advanced gastric cancer. Chemotherapy remains the mainstay of treatment for these patients, but combination chemotherapy has encountered a bottleneck in improving patient survival, with no significant improvement in survival rates at 1, 3 or 5 years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Metastases
- What is being tested?
- Tislelizumab in Combination with Oxaliplatin and Tegafur
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2022to 31 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III)
- Presence of clearly measurable (meeting RECIST 1.1 criteria) liver metastases on imaging assessment and no more than three metastases with a maximum individual diameter of no more than 5 cm
- No previous systemic treatment for advanced or metastatic gastric cancer
- Age 18 - 75 years old
- Eastern Cooperative Oncology Group physical status score of 0 or 1
- Laboratory Tests Tolerant of Chemotherapy
- Hematological Examination: no obvious signs of haematological disease, ANC ≥ 1.5 × 10^9/L, platelet count ≥ 80 × 10^9/L, Hb ≥ 90 g/L, WBC ≥ 3.0 × 10^9/L prior to enrolment and no bleeding tendency
- Biochemical examination: total bilirubin < 1.5 times the upper limit of normal, AST and ALT < 2.5 times the upper limit of normal, creatinine < 1.5 times the upper limit of normal
Who cannot join
- Other pathological type of tumor
- Presence of metastases to organs other than the liver
- Pregnant or lactating women
- Those with a history of other malignant neoplastic disease in the last 5 years
- those with a history of uncontrolled epilepsy, central nervous system disease or psychiatric disorder, where the investigator will determine whether the clinical severity prevents the signing of an informed consent or affects the patient's compliance with oral medication;
- Clinically severe (i.e. active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months
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- Have severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc
- Those with digestive tract obstruction or physiological abnormalities, or suffering from malabsorption syndrome, which may affect the absorption of S-1
- Those who have had gastrointestinal bleeding in the last two weeks, or are at high risk of bleeding as judged by the investigator
- Known to have peripheral nerve disease ≥ NCI-CTC AE grade 1. but with deep tendon reflexes (DTR) only
- Those requiring immunosuppressive therapy for organ transplantation
- Presence of any active, known or suspected autoimmune disease
- Those with uncontrolled severe infections, or other severe concomitant diseases
- Those with hypersensitivity to S-1, Oxaliplatin, Tislelizumab or any of the study drug components.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
gastrointestinal department of second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Xiaoli Jin, doctor, 86-13605809870, Jinxiaoli@zju.edu.cn
About this study
Official title: An Exploratory Study of Tislelizumab in Combination With Oxaliplatin and Tegafur for the Treatment of Gastric Cancer With Liver Metastases
Liver metastases are one of the most common sites of metastasis in advanced gastric cancer. Chemotherapy remains the mainstay of treatment for these patients, but combination chemotherapy has encountered a bottleneck in improving patient survival, with no significant improvement in survival rates at 1, 3 or 5 years. In a previous phase II clinical study we not only observed the survival benefits of Tislelizumab in the treatment of GI tumors such as liver, oesophageal and some gastric cancers, but also confirmed the safety of Tislelizumab in the treatment of advanced GI tumors. This study is a clinical study of PD-1 monoclonal antibody (Tislelizumab) in combination with SOX (Tegafur + Oxaliplatin) for the treatment of liver metastases from gastric cancer. It aims to further explore a new combination therapy for liver metastases from gastric cancer, which is safe and effective for patients with difficult-to-treat disease.
- Conditions
- Liver Metastases
- Being tested
- Tislelizumab in Combination with Oxaliplatin and Tegafur
- Keywords
- gastric cancer, immunotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab in Combination with Oxaliplatin and TegafurDrug
6 cycles of Tislelizumab plus SOX regimen every 21 days
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | patients in this arm will be treated with Tislelizumab in Combination with Oxaliplatin and Tegafur Receives: Drug: Tislelizumab in Combination with Oxaliplatin and Tegafur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The percentage of people in the study who have a partial or complete response to the treatment after 6 cycles of Tislelizumab +Tegafur + Oxaliplatin, according to RECIST1.1
Measured: about 6 months after the enrollment
Secondary outcomes (1)
progression-free survival
The length of time during and after the treatment, that liver metastasis does not get bigger or present new sites of metastasis, according to RECIST1.1
Measured: up to 12 months after the end of last cycle of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start10 Apr 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Chen, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325528
- Sponsor's protocol ID
- ZRWC_GC_I001
- Status last verified
- Jan 2023
- First submitted
- 21 Mar 2022
- Last updated
- 1 Feb 2023
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Tislelizumab in Combination With Oxaliplatin and Tegafur for the Treatment of Gastric Cancer With Liver Metastases
- ClinicalTrials.gov ID
- NCT05325528
- Acronym / sponsor ID
- ZRWC_GC_I001
- Conditions
- Liver Metastases
- Keywords
- gastric cancer, immunotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Apr 2022 (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.
Liver metastases are one of the most common sites of metastasis in advanced gastric cancer. Chemotherapy remains the mainstay of treatment for these patients, but combination chemotherapy has encountered a bottleneck in improving patient survival, with no significant improvement in survival rates at 1, 3 or 5 years. In a previous phase II clinical study we not only observed the survival benefits of Tislelizumab in the treatment of GI tumors such as liver, oesophageal and some gastric cancers, but also confirmed the safety of Tislelizumab in the treatment of advanced GI tumors. This study is a clinical study of PD-1 monoclonal antibody (Tislelizumab) in combination with SOX (Tegafur + Oxaliplatin) for the treatment of liver metastases from gastric cancer. It aims to further explore a new combination therapy for liver metastases from gastric cancer, which is safe and effective for patients with difficult-to-treat disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Tislelizumab in Combination with Oxaliplatin and Tegafurpatients in this arm will be treated with Tislelizumab in Combination with Oxaliplatin and Tegafur |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III)
- Presence of clearly measurable (meeting RECIST 1.1 criteria) liver metastases on imaging assessment and no more than three metastases with a maximum individual diameter of no more than 5 cm
- No previous systemic treatment for advanced or metastatic gastric cancer
- Age 18 - 75 years old
- Eastern Cooperative Oncology Group physical status score of 0 or 1
Key exclusion criteria (14 listed)
- Other pathological type of tumor
- Presence of metastases to organs other than the liver
- Pregnant or lactating women
- Those with a history of other malignant neoplastic disease in the last 5 years
- those with a history of uncontrolled epilepsy, central nervous system disease or psychiatric disorder, where the investigator will determine whether the clinical severity prevents the signing of an informed consent or affects the patient's compliance with oral medication;
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 |
|---|---|---|
| Tislelizumab in Combination with Oxaliplatin and Tegafur6 cycles of Tislelizumab plus SOX regimen every 21 days | Drug | study group |
Primary outcome
Objective Response Rate (ORR)
Time frame: about 6 months after the enrollment
The percentage of people in the study who have a partial or complete response to the treatment after 6 cycles of Tislelizumab +Tegafur + Oxaliplatin, according to RECIST1.1
1 secondary outcome
progression-free survival
Time frame: up to 12 months after the end of last cycle of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tislelizumab in Combination with Oxaliplatin and Tegafur in people with Liver Metastases, run by Zhejiang University 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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Jin, Doctor (86-13605809870, Jinxiaoli@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: about 6 months after the enrollment). 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 1 Feb 2023.