Gastric CancerPhase 2NCT05751265
Tislelizumab Combined With Chemotherapy in the Cross-line Treatment of First-line Resistant Advanced Gastric Cancer
A Phase 2 study testing Tislelizumab, 5Fu and Paclitaxel injection in people with Gastric Cancer, run by Fujian Cancer Hospital.
Trial summary
To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of advanced gastric cancer after first-line resistance 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, 5Fu and Paclitaxel injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jun 2025
- Phase
- Phase 2
- 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
- Gastric adenocarcinoma confirmed by pathology (including histology or cytology) and locally advanced or metastatic (stage IV) tumor that is unresectable; There is no known HER2+.
- Age 18-75;
- ECOG score: 0-2;
- Patients who had previously failed first-line immunization combined with chemotherapy (oxaliplatin combined with capecitabine or FP);
- Adequate organ and bone marrow function, meeting the following definitions:
- Blood routine (no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no other drug correction within 14 days before treatment);Absolute count of neutrophils (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥80×109/L;
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- Blood biochemistry Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min;Serum albumin ≥2.8g/dL, for patients with poor nutritional status before neoadjuvant therapy, patients who met the requirements through parenteral nutrition could also be included in the group;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
- Expected survival > 6 months;
- Fertile female subjects and male subjects whose partners are of childbearing age are required to use a medically approved contraceptive during the study treatment period and for at least 3 months after the last treatment;
- Patients who volunteered to participate in this study and signed informed consent.
- According to RECIST1.1 criteria, the patient had at least one target lesion with a measurable diameter (tumor lesion with long diameter ≥10mm, lymph node lesion with short diameter ≥15mm, scanning layer thickness 5mm);
Who cannot join
- Patients who received first-line immunotherapy for less than 3 months or experienced hyperprogression in first-line therapy or developed Grade 3 or above irAE during first-line therapy;
- Patients who have previously received other immunotherapy (including other investigational drugs) with less than 5 half-lives since the initial investigational drug use.
- Pregnant or lactating women;
- Participants who participated in other clinical studies and did not recover toxic reactions 28 days before enrollment;
- Have had other malignancies in the last 5 years or at the same time, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- Severe heart, liver, lung and kidney diseases; Neurological and mental diseases;
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- The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases, which may be characterized by the presence of clinical symptoms, cerebral edema, spinal cord compression meningitis, pia meningeal disease, and/or progressive growth.For patients with CNS metastases that are adequately treated and whose neurological symptoms return to baseline at least 2 weeks prior to randomization (residual signs or symptoms associated with CNS treatment can be enrolled.In addition, subjects must either stop corticosteroids or receive prednisone (or an equivalent dose of another corticosteroid) at least 2 weeks prior to randomization;
- Patients with hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) who cannot be reduced to the normal range after antihypertensive medication;
- Patients with grade I or above coronary heart disease, arrhythmias (including prolonged QTc interval > 450 ms in men and > 470 ms in women), and cardiac insufficiency;
- Patients with abnormal coagulation function (INR>1.5, APTT>1.5 ULN);
- Patients with a history of cardiovascular and cerebrovascular diseases who are still taking thrombolytic drugs or anticoagulants orally.
- Presence of any active, known or suspected autoimmune disease.Subjects who are in a stable state and do not require systemic immunosuppressive therapy are admitted: e.g., type 1 diabetes, hypothyroidism requiring hormone replacement therapy only, and skin conditions requiring no systemic therapy (e.g., vitiligo, psoriasis, and alopecia).
- Concurrent autoimmune diseases or a history of chronic or recurrent immune diseases, including a history of immunodeficiency such as HIV-positive testing or a history of organ transplantation and allogeneic bone marrow transplantation.
- Patients with other concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study;
- Patients with uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity is judged by the investigator to be likely to prevent the signing of informed consent or have multiple factors affecting oral medication (such as inability to swallow, persistent uncontrollable nausea and vomiting, chronic diarrhea, and intestinal obstruction);
- Allergic to the test drug or its excipients;
- Persons deemed unsuitable for inclusion by the researcher.
Trial locations and contacts
No sites are listed yet.
Li hui, Doctor contact
About this study
Official title: Tislelizumab Combined With Chemotherapy in the Cross-line Treatment of First-line Resistant Advanced Gastric Cancer, Single-arm, Exploratory Clinical Study
To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of advanced gastric cancer after first-line resistance
- Conditions
- Gastric Cancer
- Being tested
- Tislelizumab, 5Fu, Paclitaxel injection
- 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
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks . Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.
5FuDrug
Participants will receive 5-FU, 2.4 g/m2，bid，d1-d14，q3w
Paclitaxel injectionDrug
Participants will receive paclitaxel 135 mg/m2 ivgtt q2w or 175mg/m2 q3w
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with chemotherapy | Experimental | Not described Receives: Drug: Tislelizumab; Drug: 5Fu; Drug: Paclitaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Measured: At the end of Cycle 3 (each cycle is 21 days)
Secondary outcomes (1)
Progression-free survival
The length of time from enrollment until the time of progression of disease
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (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 Fujian Cancer HospitalThe 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
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751265
- Sponsor's protocol ID
- GC-01
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 22 Jun 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tislelizumab Combined With Chemotherapy in the Cross-line Treatment of First-line Resistant Advanced Gastric Cancer, Single-arm, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT05751265
- Acronym / sponsor ID
- GC-01
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 2 Mar 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.
To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of advanced gastric cancer after first-line resistance
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with chemotherapy | Experimental | Drug: Tislelizumab, Drug: 5Fu, Drug: Paclitaxel injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Gastric adenocarcinoma confirmed by pathology (including histology or cytology) and locally advanced or metastatic (stage IV) tumor that is unresectable; There is no known HER2+.
- Age 18-75;
- ECOG score: 0-2;
- Patients who had previously failed first-line immunization combined with chemotherapy (oxaliplatin combined with capecitabine or FP);
- Adequate organ and bone marrow function, meeting the following definitions:
Key exclusion criteria (17 listed)
- Patients who received first-line immunotherapy for less than 3 months or experienced hyperprogression in first-line therapy or developed Grade 3 or above irAE during first-line therapy;
- Patients who have previously received other immunotherapy (including other investigational drugs) with less than 5 half-lives since the initial investigational drug use.
- Pregnant or lactating women;
- Participants who participated in other clinical studies and did not recover toxic reactions 28 days before enrollment;
- Have had other malignancies in the last 5 years or at the same time, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
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 |
|---|---|---|
| TislelizumabParticipants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks . Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle. | Drug | Tislelizumab combined with chemotherapy |
| 5FuParticipants will receive 5-FU, 2.4 g/m2，bid，d1-d14，q3w | Drug | Tislelizumab combined with chemotherapy |
| Paclitaxel injectionParticipants will receive paclitaxel 135 mg/m2 ivgtt q2w or 175mg/m2 q3w | Drug | Tislelizumab combined with chemotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: At the end of Cycle 3 (each cycle is 21 days)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
1 secondary outcome
Progression-free survival
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 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. This study is not recruiting at the moment.
Li hui, Doctor contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, 5Fu and Paclitaxel injection in people with Gastric Cancer, run by Fujian Cancer Hospital.
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 11 inclusion and 17 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 22 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li hui, Doctor (13600855801), 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: At the end of Cycle 3 (each cycle is 21 days)). 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 22 Jun 2023.