NCT05497739

Brief Summary

Peritoneal metastasis is a major pattern of gastric cancer recurrence and predicts poor prognosis. In our previous study, we developed a next-generation sequencing technology to detect minimal residual cancer cells in peritoneal lavage fluid with a personalized assay profiling tumor-specific mutations in patients with gastric cancer. With this technology, we predicted all the cases that developed peritoneal metastasis in patients with pT4 disease with 100% sensitivity and 91% specificity. Based on this result, a prospective phase 2 clinical trial is designed to evaluate the efficacy of adjuvant intraperitoneal chemotherapy in patients with positive cancer cell DNA detected in peritoneal lavage fluid by our personalized tumor-specific mutation profiling assay.

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
68

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_2 gastric-cancer

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

June 28, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

August 10, 2022

Last Update Submit

August 10, 2022

Conditions

Gastric Cancer

Keywords

Peritoneal metastasisPersonalized mutation assayCancer cell DNAIntraperitoneal Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • The incidence of peritoneal metastasis

    The incidence of peritoneal metastasis.

    Two years after surgery.

Secondary Outcomes (4)

  • Peritoneal metastasis-free survival

    Two years after surgery.

  • Disease-free survival

    Three years after surgery.

  • Overall survival

    Three years after surgery.

  • The safety

    Ninety days after surgery.

Study Arms (1)

Intraperitoneal chemotherapy group

EXPERIMENTAL

In this study, patients with positive peritoneal lavage fluid cancer cell DNA will be given intraperitoneal chemotherapy followed by adjuvant systemic chemotherapy.

Drug: Intraperitoneal chemotherapyDrug: Adjuvant systemic chemotherapy

Interventions

Intraperitoneal chemotherapyDRUG

5-Fu 1 g/m\^2 on Days 1, 8, 15, and 22; Albumin-paclitaxel 80-100 mg/time on Days 1, 8, 15, and 22; Cisplatin 25 mg/m\^2 on Days 4, 11, 18, and 25; Interleukin-2 2 million units/time on Days 4, 11, 18, and 25.

Intraperitoneal chemotherapy group
Adjuvant systemic chemotherapyDRUG

Oxaliplatin 85 mg/m\^2 on Day 1; S-1 depends on Body Surface Area (BSA), 40 mg Bid, Days 1-10 (BSA \< 1.25 m\^2), 50 mg Bid, Days 1-10 (BSA 1.25-1.50 m\^2), 60 mg Bid, Days 1-10 (BSA \> 1.50 m\^2).

Intraperitoneal chemotherapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Currently participating in or receiving other clinical trial treatment;
  • Contraindications to investigational chemotherapy regimen including allergies to any of the chemotherapy medications;
  • Active infection requires systemic treatment;
  • Patients with poor compliance;
  • Patients who undergo non-curative surgery;
  • History of other malignant neoplasm within 5 years, except for early-stage skin cancer;
  • Pregnant or breast-feeding female;
  • Patients who have received neoadjuvant therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Central Study Contacts

Chunxia Du, M.D.

CONTACT

+86-010-87788130retinadcx@vip.163.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
Senior doctor

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 11, 2022

Study Start

June 28, 2022

Primary Completion

June 20, 2024

Study Completion

June 20, 2024

Last Updated

August 11, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)