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Trial Title:
Intraperitoneal Chemotherapy Guided by the Detection of DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer
NCT ID:
NCT05497739
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Peritoneal metastasis
Personalized mutation assay
Cancer cell DNA
Intraperitoneal Chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Intraperitoneal chemotherapy
Description:
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.
Arm group label:
Intraperitoneal chemotherapy group
Intervention type:
Drug
Intervention name:
Adjuvant systemic chemotherapy
Description:
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).
Arm group label:
Intraperitoneal chemotherapy group
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.
Criteria for eligibility:
Criteria:
Criteria:
1. Gastric adenocarcinoma confirmed by pathology (histology);
2. 18-75 years old;
3. Clinical T4 stage, no distant metastasis confirmed by CT and endoscopic
ultrasonography (EUS), potentially curable by surgery;
4. Eastern Cooperative Oncology Group Performance Score 0 or 1;
5. Absolute neutrophil count at least 1.5×10^9/L; platelets count at least 80×10^9/L;
hemoglobin at least 9 g/dL; serum creatinine or creatinine clearance no greater than
1.5 times upper normal limit (UNL); TSB no greater than 1.5 times ULN; AST (SGOT)
and ALT (SGPT) no greater than 2.0 times ULN; albumin at least 3.0 mg/dL;
6. Provide tumor tissue, blood, and peritoneal lavage fluid samples;
7. Willing to accept long-term follow-up;
8. Ability to understand and sign a written informed consent before the trial
procedure.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Dongbing Zhao, M.D.
Phone:
+86-13901331816
Email:
dbzhao2003@sina.com
Start date:
June 28, 2022
Completion date:
June 20, 2024
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05497739