New spray chemotherapy trial targets Stomach-Lining cancer
NCT ID NCT07349043
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new way to deliver chemotherapy for colorectal cancer that has spread to the lining of the abdomen. Doctors use a spray (PIPAC) to send the drugs mitomycin or raltitrexed directly into the belly during a keyhole surgery. The main goal is to find a safe dose and check for side effects in 42 adults who are also getting standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mitomycin or raltitrexed delivered as a pressurized aerosol into the abdomen
- What this could lead to
- If this works, it could offer a new way to control colorectal cancer that has spread to the abdomen, potentially improving survival when combined with standard chemotherapy.
- What could go wrong
- This is a very early Phase 1 trial with only 42 people, focused on finding a safe dose, not proving it works. The treatment may cause side effects like nausea, fatigue, or pain, and it is unclear if it will actually help patients live longer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with peritoneal metastatic adenocarcinoma of colorectal origin, confirmed by histopathology, and without metastasis to other sites. 2. No gender limitation, aged 18 to 75 years old; 3. ECOG score ≤2; 4. Subjects without other malignant diseases; 5. Subjects without laparoscopic surgery contraindications; 6. Expected survival period \> 6 months; 7. Able to comprehend and sign the informed consent form; 8. The function of important organs should meet the following requirements; The absolute neutrophil count (ANC) is ≥1.5×10\^9/L; Platelets ≥ 100×10\^9/L; Hemoglobin ≥8.0g/dl (Note: It is acceptable to achieve hemoglobin ≥8.0g/dl through blood transfusion or other interventions); serum albumin ≥2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST ≤1.5 times ULN; if there is liver metastasis, ALT and AST ≤5 times ULN; Creatinine clearance rate ≥50mL/min Exclusion Criteria: 1. Subjects with gastrointestinal obstruction; 2. Subjects who rely entirely on parenteral nutrition; 3. Subjects with decompensated ascites; 4. Subjects with severe abdominal infection (peritonitis); 5. Subjects with extensive abdominal adhesion; 6. Subjects who underwent both tumor reduction surgery and gastrointestinal resection and reconstruction simultaneously; 7. Subjects with portal vein thrombosis; 8. Patients with severe or uncontrolled medical conditions and infections (including atrial fibrillation, angina pectoris, heart failure, ejection fraction less than 50%, refractory hypertension, etc.); 9. Previously allergic to chemotherapy drugs; 10. Individuals with severe heart and lung, liver and kidney, blood system, or mental illnesses, as well as those who abuse drugs; 11. Pregnant or lactating women; 12. Patients who have participated in or are currently participating in other clinical trials within 3 months; 13. Other situations where the researchers believe that the patient is not suitable to participate in this trial; 14. Previously had a history of neurological or psychiatric disorders that would affect study informed consent or follow-up evaluation, such as severe depression or dementia;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Second Affiliated Hospital, Zhejiang University School of Medicine 88 Jiefang Road Hangzhou, Zhejiang 310009, China
RECRUITINGHangzhou, Other (Non U.s.), 310000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug wipe out hidden cancer DNA and stop colorectal cancer from returning?
- Can protein patterns in stored tumors point to new treatment targets?
- Can a new drug combo shrink advanced colorectal tumors?
- Can surgery after drug therapy beat drugs alone for stomach cancer spread?
- Can a Three-Drug attack shrink stomach cancer in the abdomen?
- Can a four-pronged attack shrink liver tumors enough for surgery?