Gastric CancerPhase 2NCT06123455
Clinical Study of Taurine Combined With Sintilimab and Chemotherapy for Treatment of Advanced Gastric Cancer
A Phase 2 study testing Taurine, Sintilimab and XELOX regimen in people with Gastric Cancer, run by Tang-Du Hospital at 1 site in China.
Trial summary
This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Taurine, Sintilimab and XELOX regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older, no gender limitation;
- Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer;
- Expected survival of ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- At least one measurable lesion outside the stomach (RECIST 1.1);
- Patients informed about the purpose and course of the study and provided a written consent to participate.
Who cannot join
- Use of taurine agent within 1 month prior to randomization on this study;
- Patients received prior systemic therapy for gastric cancer;
- Patients with operable gastric cancer;
- Patients with positive HER-2 and willing to receive herceptin treatment;
- Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
- Patients with active autoimmune disease that has required systemic treatment in past 2 years;
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- Patients diagnosed as immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy;
- Patients with severe heart, lung, liver, kidney, endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
- Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
- Other conditions that the investigator thinks are not suitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tang-Du Hospital
Xi'an, Shaanxi, 710038
Xin Wang, MD, PhD, 13571826689, wangx@fmmu.edu.cn
Jia Yu, MD, 1862928617, yj1862928617@163.com
About this study
Official title: A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer
This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone.
- Conditions
- Gastric Cancer
- Being tested
- Taurine, Sintilimab, XELOX regimen, SOX regimen, FOLFOX regimen
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurineDietary supplement
Taurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day.
SintilimabBiological
Sintilimab
XELOX regimenDrug
Oxaliplatin + capecitabine
SOX regimenDrug
Oxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium)
FOLFOX regimenDrug
Oxaliplatin + leucovorin + fluorouracil
| Study group | Role | What they receive |
|---|---|---|
| Taurine + Sintilimab + investigator's choice chemotherapy | Experimental | Taurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX Receives: Dietary Supplement: Taurine; Biological: Sintilimab; Drug: XELOX regimen; Drug: SOX regimen; Drug: FOLFOX regimen |
| Sintilimab + investigator's choice chemotherapy | Active comparator | Sintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX Receives: Biological: Sintilimab; Drug: XELOX regimen; Drug: SOX regimen; Drug: FOLFOX regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on independent radiology review or death due to any cause, whichever occurs first.
Measured: Up to 24 months
Overall survival (OS)
OS was defined as the time from randomization to death due to any cause.
Measured: Up to 24 months
Secondary outcomes (2)
Objective response rate (ORR)
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
Measured: Up to 24 months
Safety profile
Number of study subjects experiencing adverse events (AEs), dose-limiting toxicities, and serious adverse events (SAEs). Safety profile will be assessed through laboratory evaluations, vital signs, and physical examinations.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 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 Tang-Du 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Wang, MD, PhD, Study director, Tang-Du HospitalXiaodi Zhao, MD, PhD, Principal investigator, Xi-Jing HospitalYuanyuan Lu, MD, PhD, Principal investigator, Xi-Jing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123455
- Sponsor's protocol ID
- K202309-06
- Status last verified
- Nov 2023
- First submitted
- 20 Sep 2023
- Last updated
- 8 Nov 2023
- 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 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Clinical Study of The Efficacy and Safety of Taurine Combined With Sintilimab and Chemotherapy Versus Sintilimab Combined With Chemotherapy for Treatment of Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06123455
- Acronym / sponsor ID
- K202309-06
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 8 Nov 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.
This project aims to evaluate the efficacy and safety of oral taurine supplementation combined with PD-1 inhibitor (sintilimab) and chemotherapy in inducing systemic CD8+ T cell responses and achieving improved gastric cancer patient outcomes than with sintilimab and chemotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taurine + Sintilimab + investigator's choice chemotherapy | Experimental | Dietary Supplement: Taurine, Biological: Sintilimab, Drug: XELOX regimen, Drug: SOX regimen, Drug: FOLFOX regimenTaurine + Sintilimab + XELOX or Taurine + Sintilimab + SOX or Taurine + Sintilimab + FOLFOX |
| Sintilimab + investigator's choice chemotherapy | Active comparator | Biological: Sintilimab, Drug: XELOX regimen, Drug: SOX regimen, Drug: FOLFOX regimenSintilimab + XELOX or Sintilimab + SOX or Sintilimab + FOLFOX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older, no gender limitation;
- Pathologically confirmed gastric cancer or adenocarcinoma of the gastroesophageal junction, local lesions cannot be radically resected or metastatic gastric cancer;
- Expected survival of ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- At least one measurable lesion outside the stomach (RECIST 1.1);
Key exclusion criteria (10 listed)
- Use of taurine agent within 1 month prior to randomization on this study;
- Patients received prior systemic therapy for gastric cancer;
- Patients with operable gastric cancer;
- Patients with positive HER-2 and willing to receive herceptin treatment;
- Patients with gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia;
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 |
|---|---|---|
| TaurineTaurine supplementation in capsules of 1.0 gram of taurine powder. Dosage: 2.0 gram/day. Frequency: 2 time/day. | Dietary supplement | Taurine + Sintilimab + investigator's choice chemotherapy |
| SintilimabSintilimab | Biological | Sintilimab + investigator's choice chemotherapy, Taurine + Sintilimab + investigator's choice chemotherapy |
| XELOX regimenOxaliplatin + capecitabine | Drug | Sintilimab + investigator's choice chemotherapy, Taurine + Sintilimab + investigator's choice chemotherapy |
| SOX regimenOxaliplatin + S-1 (tegafur/gimeracil/oteracil potassium) | Drug | Sintilimab + investigator's choice chemotherapy, Taurine + Sintilimab + investigator's choice chemotherapy |
| FOLFOX regimenOxaliplatin + leucovorin + fluorouracil | Drug | Sintilimab + investigator's choice chemotherapy, Taurine + Sintilimab + investigator's choice chemotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: Up to 24 months
PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on independent radiology review or death due to any cause, whichever occurs first.
Overall survival (OS)
Time frame: Up to 24 months
OS was defined as the time from randomization to death due to any cause.
2 secondary outcomes
Objective response rate (ORR)
Time frame: Up to 24 months
Safety profile
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 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.
Xin Wang, MD, PhD study director
Tang-Du Hospital
Xiaodi Zhao, MD, PhD principal investigator
Xi-Jing Hospital
Yuanyuan Lu, MD, PhD principal investigator
Xi-Jing 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 Taurine, Sintilimab and XELOX regimen in people with Gastric Cancer, run by Tang-Du 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 6 inclusion and 10 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 8 Nov 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 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 Xiaodi Zhao, MD, PhD (17702979587, leedyzhao@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 8 Nov 2023.