Gastric Cancer Stage IVPhase 2NCT05204173
Efficacy and Safety of Sintilimab Combined Intraperitoneal and Intravenous Paclitaxel Plus Oral S-1 in Gastric Cancer Patients With Peritoneal Metastasis
A Phase 2 study testing sintilimab, paclitaxel and S-1 in people with Gastric Cancer Stage IV and Peritoneal Metastases, run by Ruijin Hospital at 1 site in China.
Trial summary
In this phase 2 study, we combined sintilimab, paclitaxel and S-1 as regimen to treat gastric cancer patients with peritoneal metastasis. We are aim to estimate the efficacy and safety of this regimen in the phase 2 study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer Stage IV, Peritoneal Metastases
- What is being tested?
- sintilimab, paclitaxel and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2021to Dec 2023
- 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
- Histologically confirmed gastric adenocarcinoma;
- Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction;
- Written (signed) informed consent;
- Age ≥ 18 years at registration;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
- Expected life expectancy > 3 months;
- Adequate bone marrow, liver, and renal functions. absolute neutrophil count of ≥1.5×109/L; absolute neutrophil count of ≥1.5×109/L; platelet count of ≥100×109/L; hemoglobin ≥90g/L; bilirubin of <1.5×upper limit of normal [ULN]; alanine aminotransferase and aspartate aminotransferase of <2.5×ULN; serum creatinine of ≤1.5×ULN; creatinine clearance of >50 mL/min; TSH ≤1×ULN (if abnormal, T3 and T4 levels should be inspected at the same time, if T3 and T4 levels are normal, they can be included in the group); APTT ≤1.5×ULN and INR ≤1.5×ULN; myocardial enzymogram ≤1×ULN.
Who cannot join
- Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);
- During pregnancy, within 28 days of post parturition, or during lactation;
- Synchronous or metachronous (within 5 years) malignancies.
- Severe mental disease, uncontrolled epilepsy, or central nervous system disease;
- Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months;
- Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome may affect S-1 absorbers;
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- Known peripheral neuropathy (> NCI-CTC AE 1). However, patients with only disappearance of deep tendon reflex (DTR) need not be excluded;
- Patients on steroid or immunosuppressant treatment after organ transplant;
- Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant disease;
- Moderate or severe renal damage [creatinine clearance ≤ 50 ml/min], or serum creatinine > upper limit of normal (ULN), 115 μmol/L;
- Known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Anaphylaxis to paclitaxel or any research drug ingredient.
- Active autoimmune disease or history of refractory autoimmune disease; Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
- HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time);
- Steroid or other systemic immunosuppressive therapy was used 14 days before admission, excluding local or physiological doses of systemic glucocorticoids (eg. no more than 10mg/day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents;
- Uncontrolled arrhythmia and myocardial infarction within 12 months before admission or active tuberculosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Zhongyin Yang, PhD, +862164370045 ext. 671304, jeffreyyong@163.com
About this study
In this phase 2 study, we combined sintilimab, paclitaxel and S-1 as regimen to treat gastric cancer patients with peritoneal metastasis. We are aim to estimate the efficacy and safety of this regimen in the phase 2 study.
Read the detailed description
Gastric cancer patients enrolled in this a phase 2 study received sintilimab (200mg intravenously on day 1), paclitaxel (PTX) (20 mg/m2 intraperitoneally and 50 mg/m2 intravenously on days 1 and 8) plus oral S-1 (80 mg/m2 for 14 consecutive days) every 3 weeks. The primary endpoint is 1-year survival rate. Secondary endpoints are adverse events, R0 resection rate, 3-year overall survival (OS), and 3-year progressive free survival. Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0.
- Conditions
- Gastric Cancer Stage IV, Peritoneal Metastases
- Being tested
- sintilimab, paclitaxel and S-1
- Keywords
- Gastric cancer, Peritoneal metastasis, Paclitaxel, Sintilimab, Chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sintilimab, paclitaxel and S-1Drug
Sintilimab 200mg intravenous (IV) infusion on day 1, PTX 50 mg/m2 IV and PTX 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days with one week rest.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal | Experimental | Sintilimab 200mg intravenous (IV) infusion on day 1, PTX 50 mg/m2 IV and PTX 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days every 3 weeks. Receives: Drug: sintilimab, paclitaxel and S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year survival rate
Measured: 12 months
Secondary outcomes (4)
Number of participants experiencing clinical and laboratory adverse events (AEs)
Measured: 24 months
R0 resection rate
Measured: 24 months
3-year overall survival (OS)
Measured: 36 months
3-year progressive free survival (PFS)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start20 May 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhuzhenggang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204173
- Sponsor's protocol ID
- DRAGON-09
- Status last verified
- Jan 2022
- First submitted
- 25 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Publications
Yuan H, Lu S, Sun DB, Yao XX, Liu WT, Zheng YN, Hua ZC, Ni ZT, He CY, Wang ZQ, Zhang J, Liu D, Jiang C, Li C, Zhang J, Yan M, Yang ZY, Shi M, Zhu ZG, Yan C. Intraperitoneal and intravenous paclitaxel plus S-1 and sintilimab as first-line treatment for gastric cancer with peritoneal metastasis: a single-arm phase 2 trial (DRAGON-09). EClinicalMedicine. 2025 Dec 29;91:103731. doi: 10.1016/j.eclinm.2025.103731. eCollection 2026 Jan.
PubMed 41542221Yuan H, Lu S, Shi M, Yang Z, Liu W, Ni Z, Yao X, Hua Z, Feng R, Zheng Y, Wang Z, Sah BK, Chen M, Zhu Z, He C, Li C, Zhang J, Yan C, Yan M, Zhu Z. Sintilimab combined neoadjuvant intraperitoneal and systemic chemotherapy in gastric cancer with peritoneal metastasis. Future Oncol. 2023 Dec;19(38):2517-2523. doi: 10.2217/fon-2022-0738. Epub 2023 May 22.
PubMed 37212686
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sintilimab Combined Intraperitoneal and Intravenous Paclitaxel Plus Oral S-1 in Gastric Cancer Patients With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT05204173
- Acronym / sponsor ID
- DRAGON-09
- Conditions
- Gastric Cancer Stage IV, Peritoneal Metastases
- Keywords
- Gastric cancer, Peritoneal metastasis, Paclitaxel, Sintilimab, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Jan 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.
In this phase 2 study, we combined sintilimab, paclitaxel and S-1 as regimen to treat gastric cancer patients with peritoneal metastasis. We are aim to estimate the efficacy and safety of this regimen in the phase 2 study.
Detailed description
Gastric cancer patients enrolled in this a phase 2 study received sintilimab (200mg intravenously on day 1), paclitaxel (PTX) (20 mg/m2 intraperitoneally and 50 mg/m2 intravenously on days 1 and 8) plus oral S-1 (80 mg/m2 for 14 consecutive days) every 3 weeks. The primary endpoint is 1-year survival rate. Secondary endpoints are adverse events, R0 resection rate, 3-year overall survival (OS), and 3-year progressive free survival. Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal | Experimental | Drug: sintilimab, paclitaxel and S-1Sintilimab 200mg intravenous (IV) infusion on day 1, PTX 50 mg/m2 IV and PTX 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed gastric adenocarcinoma;
- Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction;
- Written (signed) informed consent;
- Age ≥ 18 years at registration;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
Key exclusion criteria (16 listed)
- Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);
- During pregnancy, within 28 days of post parturition, or during lactation;
- Synchronous or metachronous (within 5 years) malignancies.
- Severe mental disease, uncontrolled epilepsy, or central nervous system disease;
- Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months;
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 |
|---|---|---|
| sintilimab, paclitaxel and S-1Sintilimab 200mg intravenous (IV) infusion on day 1, PTX 50 mg/m2 IV and PTX 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days with one week rest. | Drug | Intraperitoneal |
Primary outcome
1-year survival rate
Time frame: 12 months
4 secondary outcomes
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time frame: 24 months
R0 resection rate
Time frame: 24 months
3-year overall survival (OS)
Time frame: 36 months
3-year progressive free survival (PFS)
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Derived from this study: PubMed 41542221Yuan H, Lu S, Sun DB, Yao XX, Liu WT, Zheng YN, Hua ZC, Ni ZT, He CY, Wang ZQ, Zhang J, Liu D, Jiang C, Li C, Zhang J, Yan M, Yang ZY, Shi M, Zhu ZG, Yan C. Intraperitoneal and intravenous paclitaxel plus S-1 and sintilimab as first-line treatment for gastric cancer with peritoneal metastasis: a single-arm phase 2 trial (DRAGON-09). EClinicalMedicine. 2025 Dec 29;91:103731. doi: 10.1016/j.eclinm.2025.103731. eCollection 2026 Jan.
- Derived from this study: PubMed 37212686Yuan H, Lu S, Shi M, Yang Z, Liu W, Ni Z, Yao X, Hua Z, Feng R, Zheng Y, Wang Z, Sah BK, Chen M, Zhu Z, He C, Li C, Zhang J, Yan C, Yan M, Zhu Z. Sintilimab combined neoadjuvant intraperitoneal and systemic chemotherapy in gastric cancer with peritoneal metastasis. Future Oncol. 2023 Dec;19(38):2517-2523. doi: 10.2217/fon-2022-0738. Epub 2023 May 22.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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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 sintilimab, paclitaxel and S-1 in people with Gastric Cancer Stage IV and Peritoneal Metastases, run by Ruijin 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 7 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: status not confirmed, as of the sponsor's last update on 24 Jan 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 Zhongyin Yang, PhD (8621-64370045 ext. 671304, jeffreyyong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year survival rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05204173, which also lists 2 linked publications.
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 24 Jan 2022.