Intraperitoneal Chemotherapy Guided by the Detection of DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer

NCT ID: NCT05497739

Last Updated: 2022-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2024-06-20

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.

Detailed Description

Introduction:

Peritoneal metastasis is the most common pattern of gastric cancer recurrence and leads to rapid death. In a previous study, our team established a personalized method which could detect minimal cancer cell DNA in peritoneal lavage fluid with high sensitivity and specificity. We intend to perform a clinical trial to explore the efficacy of intraperitoneal chemotherapy on reducing the incidence of peritoneal metastases in patients with high risk defined by our personalized mutation detection method.

Methods and analysis:

This is a single-arm and single-center clinical trial. Sixty-eight patients with clinical T4 stage gastric cancers will be expected to be enrolled. During surgery, surgeons will wash upper abdominal cavity with 300-400 mL of normal saline before any manipulation of the tumor and collect about 200 mL peritoneal lavage fluid. Cancer cell DNA in peritoneal lavage fluid will be detected by next-generation sequencing using a personalized tumor-specific mutation profiling assay. Patients with positive peritoneal lavage fluid cancer cell DNA will receive adjuvant intraperitoneal chemotherapy in the second month since surgery, then followed by standard adjuvant systemic chemotherapy.

The primary endpoint is the incidence of peritoneal metastasis, and the secondary endpoints include peritoneal metastasis-free survival, disease-free survival (DFS), overall survival (OS), and the safety of intraperitoneal chemotherapy.

Ethics

This trial has been approved by the Ethics Committee of the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intraperitoneal chemotherapy group

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

Group Type: EXPERIMENTAL

Intraperitoneal chemotherapy

Intervention Type: DRUG

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.

Adjuvant systemic chemotherapy

Intervention Type: DRUG

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).

Interventions

Intraperitoneal chemotherapy

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.

Intervention Type: DRUG

Adjuvant systemic chemotherapy

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).

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

1. Currently participating in or receiving other clinical trial treatment;

2. Contraindications to investigational chemotherapy regimen including allergies to any of the chemotherapy medications;

3. Active infection requires systemic treatment;

4. Patients with poor compliance;

5. Patients who undergo non-curative surgery;

6. History of other malignant neoplasm within 5 years, except for early-stage skin cancer;

7. Pregnant or breast-feeding female;

8. Patients who have received neoadjuvant therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dong Bing Zhao

Senior doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunxia Du, M.D.

Role: CONTACT

retinadcx@vip.163.com

+86-010-87788130

Facility Contacts

Dongbing Zhao, M.D.

Role: primary

dbzhao2003@sina.com

+86-13901331816

Other Identifiers

21/458-3129

Identifier Type: -

Identifier Source: org_study_id