NCT05204173

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

December 25, 2021

Last Update Submit

January 10, 2022

Conditions

Gastric Cancer Stage IVPeritoneal Metastases

Keywords

Gastric cancerPeritoneal metastasisPaclitaxelSintilimabChemotherapy

Outcome Measures

Primary Outcomes (1)

  • 1-year survival rate

    12 months

Secondary Outcomes (4)

  • Number of participants experiencing clinical and laboratory adverse events (AEs)

    24 months

  • R0 resection rate

    24 months

  • 3-year overall survival (OS)

    36 months

  • 3-year progressive free survival (PFS)

    36 months

Study Arms (1)

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.

Drug: sintilimab, paclitaxel and S-1

Interventions

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.

Intraperitoneal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 41542221DERIVED

  • Yuan 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.

    PMID: 37212686DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimabPaclitaxelS 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Central Study Contacts

Zhongyin Yang, PhD

CONTACT

8621-64370045jeffreyyong@163.com

Min Shi, PhD

CONTACT

8621-64370045shimin0412005@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 25, 2021

First Posted

January 24, 2022

Study Start

May 20, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 24, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL

Locations

CN(1)