Locally Advanced Gastric CancerPhase 2NCT05528367
Tirelizumab in Combination With Chemoradiation in Patients With Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Nab-PTX,S-1,Tirelizumab and Chemoradiation in people with Locally Advanced Gastric Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of chemoradiotherapy combined with tirelizumab in the treatment of initial unresectable locally advanced gastric cancer or gastroesophageal junction cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric Cancer
- What is being tested?
- Nab-PTX,S-1,Tirelizumab and Chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- 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
- Male or female patients, aged ≥ 18 years; ≤ 75 years old;
- The histopathology confirmed the diagnosis of previously untreated locally advanced unresectable HER2 negative gastric or gastroesophageal junction adenocarcinoma (imaging evaluation showed that the primary tumor was severely invaded, could not be separated from the surrounding normal tissue, or had surrounded large blood vessels, or regional lymph nodes were fixed and fused, or the metastatic lymph nodes were not within the scope of surgical clearance), and there was no peritoneal metastasis during laparoscopic exploration;
- There is no serious liver and kidney function damage, and the functional level of organs must meet the following requirements: ANC ≥ 1.5 × 109/L； PLT ≥ 90 × 109/L； Hb ≥ 90 g/L； TBIL ≤ 1 × ULN； ALT and AST ≤ 1.5 × ULN，ALP ≤ 2.5 × ULN； Bun and Cr ≤ 1 × ULN and creatinine clearance ≥ 50 ml / min (Cockcroft Gault formula); LVEF ≥ 50%； The QT interval (QTCF) corrected by fridericia method was < 450 ms in males and < 470 MS in females; INR ≤ 1.5 × ULN，APTT ≤ 1.5 × ULN；
- The patient has at least one measurable lesion, which is evaluated by the investigator according to (RECIST) v1.1;
- ECoG PS score 0 or 1;
- Life expectancy ≥ 6 months;
- The investigator assessed that the patient could comply with the protocol requirements;
- Sign the informed consent document.
Who cannot join
- Received systemic cytotoxic drug chemotherapy;
- Patients with hypersensitivity or hypersensitivity to therapeutic drugs and patients with autoimmune diseases; Have received allogeneic tissue / solid organ transplantation;
- There is third space effusion (such as pleural fluid and ascites) that cannot be controlled by drainage or other methods;
- Use steroids for more than 50 days, or need to use steroids for a long time;
- Uncontrolled symptomatic brain metastases or mental disorders cannot correctly express subjective symptoms;
- The abnormal coagulation function has clinical significance, has bleeding tendency or is receiving thrombolytic or anticoagulant treatment;
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- Unable to swallow, chronic diarrhea and intestinal obstruction, and there are many factors affecting drug taking and absorption;
- Other malignant tumors occurred within 5 years before enrollment, except for cervical carcinoma in situ or skin squamous or basal cell carcinoma that had been treated for radical cure before;
- Pregnant or lactating women who have fertility but refuse to take contraceptive measures;
- Those with serious heart disease or medical history, including: recorded history of congestive heart failure, high-risk uncontrollable arrhythmia, angina pectoris requiring medical treatment, clinically clear heart valve disease, history of serious myocardial infarction and stubborn hypertension;
- According to the judgment of the investigator, there are concomitant diseases (such as uncontrolled hypertension, diabetes, thyroid disease, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study;
- The investigator determines that other conditions are not suitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liu luying
Hangzhou, Zhejiang, 310022
Liu Lu ying, MD, 571-88128142 ext. +86, luyingliu@163.com
About this study
Official title: Tirelizumab in Combination With Chemoradiation in Patients With Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma：A Single Arm Phase II Clinical Study
To evaluate the efficacy and safety of chemoradiotherapy combined with tirelizumab in the treatment of initial unresectable locally advanced gastric cancer or gastroesophageal junction cancer.
- Conditions
- Locally Advanced Gastric Cancer
- Being tested
- Nab-PTX,S-1,Tirelizumab, Chemoradiation
- Keywords
- chemoradiotherapy, tirelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-PTX,S-1,TirelizumabDrug
S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily.
Nab-PTX:130mg/m2,d1，8，q3w；100mg qw(during radiation) Tirelizumab：200mg d1 q3w.
ChemoradiationRadiation
45-50Gy/25F
| Study group | Role | What they receive |
|---|---|---|
| CRT with Tirelizumab | Experimental | Chemotherapy+Tirelizumab:PS regimen:S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily.
Nab-PTX:preoperation：130mg/m2,d1，8，q3w；adjuvant:100mg/m2,d1，8，q3w； Tirelizumab：200mg d1 q3w.
Concurrent Chemoradiotherapy:
Radiation: 45-50Gy/25Fx;During radiation: Nab-PTX:100mg qw,Tirelizumab：200mg d1 q3w.
Chemotherapy+Tirelizumab:PS regimen:S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily.
Nab-PTX:preoperation：130mg/m2,d1，8，q3w； Tirelizumab：200mg d1 q3w.
We will evaluate whether the tumor could be resectable through CT scan and Endoscope after two cycles of Chemotherapy+Tirelizumab and CRT.If it could be resctable,three cycles of adjuvant chemotherapy+Tirelizumab will be arranged;If not,another three cycles of chemotherapy+Tirelizumab will be arranged，then evaluate again. Receives: Drug: Nab-PTX,S-1,Tirelizumab; Radiation: Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of resectable patients with negative incisal margin R0 resection rate
the rate of resectable patients with negative incisal margin
Measured: 18 weeks after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu luying, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528367
- Sponsor's protocol ID
- ZhejiangCH20211029
- Status last verified
- Oct 2021
- First submitted
- 1 Sep 2022
- Last updated
- 6 Sep 2022
- 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 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tirelizumab in Combination With Chemoradiation in Patients With Unresectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma：A Single Arm Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT05528367
- Acronym / sponsor ID
- ZhejiangCH20211029
- Conditions
- Locally Advanced Gastric Cancer
- Keywords
- chemoradiotherapy, tirelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Sep 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.
To evaluate the efficacy and safety of chemoradiotherapy combined with tirelizumab in the treatment of initial unresectable locally advanced gastric cancer or gastroesophageal junction cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT with Tirelizumab | Experimental | Drug: Nab-PTX,S-1,Tirelizumab, Radiation: ChemoradiationChemotherapy+Tirelizumab:PS regimen:S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily. Nab-PTX:preoperation：130mg/m2,d1，8，q3w；adjuvant:100mg/m2,d1，8，q3w； Tirelizumab：200mg d1 q3w. Concurrent Chemoradiotherapy: Radiation: 45-50Gy/25Fx;During radiation: Nab-PTX:100mg qw,Tirelizumab：200mg d1 q3w. Chemotherapy+Tirelizumab:PS regimen:S-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily. Nab-PTX:preoperation：130mg/m2,d1，8，q3w； Tirelizumab：200mg d1 q3w. We will evaluate whether the tumor could be resectable through CT scan and Endoscope after two cycles of Chemotherapy+Tirelizumab and CRT.If it could be resctable,three cycles of adjuvant chemotherapy+Tirelizumab will be arranged;If not,another three cycles of chemotherapy+Tirelizumab will be arranged，then evaluate again. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients, aged ≥ 18 years; ≤ 75 years old;
- The histopathology confirmed the diagnosis of previously untreated locally advanced unresectable HER2 negative gastric or gastroesophageal junction adenocarcinoma (imaging evaluation showed that the primary tumor was severely invaded, could not be separated from the surrounding normal tissue, or had surrounded large blood vessels, or regional lymph nodes were fixed and fused, or the metastatic lymph nodes were not within the scope of surgical clearance), and there was no peritoneal metastasis during laparoscopic exploration;
- There is no serious liver and kidney function damage, and the functional level of organs must meet the following requirements: ANC ≥ 1.5 × 109/L； PLT ≥ 90 × 109/L； Hb ≥ 90 g/L； TBIL ≤ 1 × ULN； ALT and AST ≤ 1.5 × ULN，ALP ≤ 2.5 × ULN； Bun and Cr ≤ 1 × ULN and creatinine clearance ≥ 50 ml / min (Cockcroft Gault formula); LVEF ≥ 50%； The QT interval (QTCF) corrected by fridericia method was < 450 ms in males and < 470 MS in females; INR ≤ 1.5 × ULN，APTT ≤ 1.5 × ULN；
- The patient has at least one measurable lesion, which is evaluated by the investigator according to (RECIST) v1.1;
- ECoG PS score 0 or 1;
Key exclusion criteria (12 listed)
- Received systemic cytotoxic drug chemotherapy;
- Patients with hypersensitivity or hypersensitivity to therapeutic drugs and patients with autoimmune diseases; Have received allogeneic tissue / solid organ transplantation;
- There is third space effusion (such as pleural fluid and ascites) that cannot be controlled by drainage or other methods;
- Use steroids for more than 50 days, or need to use steroids for a long time;
- Uncontrolled symptomatic brain metastases or mental disorders cannot correctly express subjective symptoms;
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 |
|---|---|---|
| Nab-PTX,S-1,TirelizumabS-1:BSA <=1.25 m2 ,80 mg daily; 1.25 m2 <BSA <1.5 m2,100 mg daily; BSA>=1.5 m2 ,120 mg daily. Nab-PTX:130mg/m2,d1，8，q3w；100mg qw(during radiation) Tirelizumab：200mg d1 q3w. | Drug | CRT with Tirelizumab |
| Chemoradiation45-50Gy/25F | Radiation | CRT with Tirelizumab |
Primary outcome
the rate of resectable patients with negative incisal margin R0 resection rate
Time frame: 18 weeks after treatment completion
the rate of resectable patients with negative incisal margin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
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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 study testing Nab-PTX,S-1,Tirelizumab and Chemoradiation in people with Locally Advanced Gastric Cancer, run by Zhejiang Cancer Hospital 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 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: status not confirmed, as of the sponsor's last update on 6 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Lu ying, MD (0571-88128142 ext. +86, luyingliu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of resectable patients with negative incisal margin R0 resection rate (time frame: 18 weeks after treatment completion). 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 6 Sep 2022.