Gastric AdenocarcinomaEarly Phase 1NCT07034742
Exploratory Study on the Application of Molecular Residual Disease (MRD) in Postoperative Treatment of Gastric Cancer
A Early Phase 1 study testing Intraperitoneal chemotherapy PLUS systemic chemotherapy in people with Gastric Adenocarcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Gastric cancer is one of the most prevalent and lethal malignancies in China. The majority of patients are diagnosed at the locally advanced stage. Despite standard treatment involving radical resection combined with adjuvant chemotherapy, approximately 40% of patients experience recurrence and metastasis, with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Intraperitoneal chemotherapy PLUS systemic chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jan 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma of the stomach or gastroesophageal junction (GEJ).
- Clinical stage cT4NanyM0, deemed suitable for radical resection.
- Age between 18 and 75 years.
- ECOG performance status of 0 or 1.
- No prior neoadjuvant therapy and strong patient/family preference for primary surgery.
- Adequate organ function defined as:
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- Absolute neutrophil count (ANC) > 1.5 x 10⁹/L (or > 1500/µL)；Hemoglobin (Hb) > 90 g/L；Platelet count (PLT) > 100 x 10⁹/L (or > 100,000/µL)；Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 2.5 x Upper Limit of Normal (ULN)；Total bilirubin (TBIL) < 1.5 x ULN；Serum creatinine (Cr) < 1.0 x ULN
- Good compliance and willingness to undergo long-term follow-up.
- Provision of signed written informed consent.
Who cannot join
- Pathological specimens containing >10% of other histological components (e.g., squamous cell carcinoma, neuroendocrine carcinoma, etc.).
- Uncontrolled gastrointestinal obstruction or recurrent bleeding.
- Inability to swallow oral medications.
- Active infection requiring systemic therapy.
- Moderate to severe cirrhosis due to any cause.
- Cardiac function classified as NYHA class > I.
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- History of myocardial infarction, unstable angina, stroke, or uncontrolled arrhythmia.
- Anticipated inability to tolerate postoperative adjuvant chemotherapy.
- Concurrent medical conditions that contraindicate chemotherapy.
- Pregnancy or lactation; history of psychiatric illness; poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chaoyang District, Panjiayuan Nanli NO.17
Beijing
About this study
Gastric cancer is one of the most prevalent and lethal malignancies in China. The majority of patients are diagnosed at the locally advanced stage. Despite standard treatment involving radical resection combined with adjuvant chemotherapy, approximately 40% of patients experience recurrence and metastasis, with peritoneal metastasis accounting for nearly half of these cases.
Building upon our team's previous establishment of next-generation sequencing (NGS) technology for detecting molecular residual disease (MRD) in peritoneal lavage fluid and blood, this project aims to guide systemic chemotherapy with or without intraperitoneal chemotherapy for locally advanced gastric cancer patients based on the results of peritoneal lavage fluid MRD testing. We will investigate whether intraperitoneal chemotherapy can reduce the peritoneal metastasis rate in patients testing positive for MRD in peritoneal lavage fluid. The ultimate goal is to propose a novel diagnostic and therapeutic strategy for post-operative adjuvant treatment of gastric cancer, addressing this critical clinical challenge.
Patients testing negative for MRD in peritoneal lavage fluid will be enrolled in an observational cohort study. This cohort will explore the concordance between blood-based MRD positivity and actual clinical recurrence and metastasis. The objectives are to determine whether blood-based MRD can predict the occurrence of non-peritoneal metastasis after surgery and whether it can be used to evaluate the efficacy of post-operative systemic chemotherapy.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Intraperitoneal chemotherapy PLUS systemic chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal chemotherapy PLUS systemic chemotherapyDrug
Intraperitoneal chemotherapy (fluorouracil + nab-paclitaxel + cisplatin + interleukin-2) PLUS systemic chemotherapy (SOX regimen: oxaliplatin + tegafur-gimeracil-oteracil potassium)
| Study group | Role | What they receive |
|---|---|---|
| GC patients | Experimental | Not described Receives: Drug: Intraperitoneal chemotherapy PLUS systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year peritoneal metastasis-free survival rate
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jun 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 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
- NCT07034742
- Sponsor's protocol ID
- 25/099-5045
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Application of Molecular Residual Disease (MRD) in Postoperative Treatment of Gastric Cancer
- ClinicalTrials.gov ID
- NCT07034742
- Acronym / sponsor ID
- 25/099-5045
- Conditions
- Gastric Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 24 Jun 2025 (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.
Gastric cancer is one of the most prevalent and lethal malignancies in China. The majority of patients are diagnosed at the locally advanced stage. Despite standard treatment involving radical resection combined with adjuvant chemotherapy, approximately 40% of patients experience recurrence and metastasis, with peritoneal metastasis accounting for nearly half of these cases.
Building upon our team's previous establishment of next-generation sequencing (NGS) technology for detecting molecular residual disease (MRD) in peritoneal lavage fluid and blood, this project aims to guide systemic chemotherapy with or without intraperitoneal chemotherapy for locally advanced gastric cancer patients based on the results of peritoneal lavage fluid MRD testing. We will investigate whether intraperitoneal chemotherapy can reduce the peritoneal metastasis rate in patients testing positive for MRD in peritoneal lavage fluid. The ultimate goal is to propose a novel diagnostic and therapeutic strategy for post-operative adjuvant treatment of gastric cancer, addressing this critical clinical challenge.
Patients testing negative for MRD in peritoneal lavage fluid will be enrolled in an observational cohort study. This cohort will explore the concordance between blood-based MRD positivity and actual clinical recurrence and metastasis. The objectives are to determine whether blood-based MRD can predict the occurrence of non-peritoneal metastasis after surgery and whether it can be used to evaluate the efficacy of post-operative systemic chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC patients | Experimental | Drug: Intraperitoneal chemotherapy PLUS systemic chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma of the stomach or gastroesophageal junction (GEJ).
- Clinical stage cT4NanyM0, deemed suitable for radical resection.
- Age between 18 and 75 years.
- ECOG performance status of 0 or 1.
- No prior neoadjuvant therapy and strong patient/family preference for primary surgery.
Key exclusion criteria (10 listed)
- Pathological specimens containing >10% of other histological components (e.g., squamous cell carcinoma, neuroendocrine carcinoma, etc.).
- Uncontrolled gastrointestinal obstruction or recurrent bleeding.
- Inability to swallow oral medications.
- Active infection requiring systemic therapy.
- Moderate to severe cirrhosis due to any cause.
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 chemotherapy PLUS systemic chemotherapyIntraperitoneal chemotherapy (fluorouracil + nab-paclitaxel + cisplatin + interleukin-2) PLUS systemic chemotherapy (SOX regimen: oxaliplatin + tegafur-gimeracil-oteracil potassium) | Drug | GC patients |
Primary outcome
2-year peritoneal metastasis-free survival rate
Time frame: 2-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intraperitoneal chemotherapy PLUS systemic chemotherapy in people with Gastric Adenocarcinoma, 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongbing Zhao (010-87787120, dbzhao@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year peritoneal metastasis-free survival rate (time frame: 2-year). 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 24 Jun 2025.