Gastric CancerPhase 2NCT05497739
Intraperitoneal Chemotherapy Guided by the Detection of DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer
A Phase 2 study testing Intraperitoneal chemotherapy and Adjuvant systemic chemotherapy in people with Gastric Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Intraperitoneal chemotherapy and Adjuvant systemic chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2022to 20 Jun 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, 100021
Dongbing Zhao, M.D., +86-13901331816, dbzhao2003@sina.com
About this study
Official title: Adjuvant Intraperitoneal Chemotherapy Guided by the Detection of Cancer Cell DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer: an Open-label, Phase 2 Trial
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.
Read the 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
- Being tested
- Intraperitoneal chemotherapy, Adjuvant systemic chemotherapy
- Keywords
- Peritoneal metastasis, Personalized mutation assay, Cancer cell DNA, Intraperitoneal 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.
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intraperitoneal chemotherapy; Drug: Adjuvant systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of peritoneal metastasis
The incidence of peritoneal metastasis.
Measured: Two years after surgery.
Secondary outcomes (4)
Peritoneal metastasis-free survival
The time from surgery to peritoneal metastasis.
Measured: Two years after surgery.
Disease-free survival
The time from surgery to either recurrence or relapse of cancer, or death.
Measured: Three years after surgery.
Overall survival
The time from surgery to death or the last follow-up date.
Measured: Three years after surgery.
The safety
Adverse event and complications related to intraperitoneal chemotherapy. Adverse event is defined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Complications will be recorded and graded according to the modified Clavien-Dindo classification.
Measured: Ninety days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start28 Jun 2022
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Bing Zhao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497739
- Sponsor's protocol ID
- 21/458-3129
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Intraperitoneal Chemotherapy Guided by the Detection of Cancer Cell DNA in Peritoneal Lavage Fluid in Patients With Gastric Cancer: an Open-label, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05497739
- Acronym / sponsor ID
- 21/458-3129
- Conditions
- Gastric Cancer
- Keywords
- Peritoneal metastasis, Personalized mutation assay, Cancer cell DNA, Intraperitoneal Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 11 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal chemotherapy group | Experimental | Drug: Intraperitoneal chemotherapy, Drug: Adjuvant systemic chemotherapyIn this study, patients with positive peritoneal lavage fluid cancer cell DNA will be given intraperitoneal chemotherapy followed by adjuvant systemic chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Intraperitoneal chemotherapy5-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. | Drug | Intraperitoneal chemotherapy group |
| Adjuvant systemic chemotherapyOxaliplatin 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). | Drug | Intraperitoneal chemotherapy group |
Primary outcome
The incidence of peritoneal metastasis
Time frame: Two years after surgery.
The incidence of peritoneal metastasis.
4 secondary outcomes
Peritoneal metastasis-free survival
Time frame: Two years after surgery.
Disease-free survival
Time frame: Three years after surgery.
Overall survival
Time frame: Three years after surgery.
The safety
Time frame: Ninety days after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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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 Intraperitoneal chemotherapy and Adjuvant systemic chemotherapy in people with Gastric Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 0 inclusion and 8 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 11 Aug 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 Chunxia Du, M.D. (+86-010-87788130, retinadcx@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of peritoneal metastasis (time frame: Two years after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2022.