Baking soda and chemo combo takes on tough pancreatic cancer
NCT ID NCT07504471
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for pancreatic cancer that has spread to the liver. Doctors deliver a mix of sodium bicarbonate (baking soda), chemotherapy drugs, and an immunotherapy drug directly into the liver's blood supply. The goal is to see if this approach helps people live longer. The trial is recruiting 50 adults with this specific type of cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sodium bicarbonate, liposomal irinotecan, oxaliplatin, S-1, and a PD-1 inhibitor
- What this could lead to
- If successful, this could offer a new treatment option for people with pancreatic cancer that has spread to the liver, potentially improving survival.
- What could go wrong
- This is an early Phase II trial with only 50 participants, so results may not apply to everyone. The combination therapy has risks like side effects from chemotherapy and immunotherapy, and it may not work better than current treatments.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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 years and older
- 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: * Aged 18 years and above, with no gender restrictions; * Pathologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium), with metastasis to the liver; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; * Adequate organ function, meeting the following criteria: a. Hematological tests: 1. Neutrophils ≥ 1.5 × 10⁹ /L; 2. White blood cells ≥ 3.0 × 10⁹ /L; 3. Platelets ≥ 85 × 10⁹ /L; 4. Hemoglobin ≥ 70 g/L; b. Biochemical tests: <!-- --> 1. Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN); 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN; 3. Albumin level ≥ 28 g/L; 4. Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests: <!-- --> 1. Normal electrocardiogram (ECG) or ECG abnormalities deemed clinically insignificant by the investigator; 2. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal; * At least 3 weeks post-surgery, radiotherapy, chemotherapy, or other anti-tumor treatments, with general physical condition or related adverse reactions having recovered (toxicity ≤ grade 1) or stabilized; * Willing to participate and sign the informed consent form; * Good compliance and agreement to cooperate with survival follow-up. Exclusion Criteria: * Subjects with ascites requiring clinical intervention (including moderate to large amounts of ascites; subjects with ascites need to be stable for more than 4 weeks after drainage); * Clinically severe gastrointestinal diseases (including bleeding, infectious inflammation, perforation, obstruction, or diarrhea greater than grade 1); * NRS pain score ≥ 4 after standardized treatment with analgesics; * Second primary malignancy within 5 years (except cured carcinoma in situ, basal cell, or squamous cell skin cancer; subjects with other previous tumors can be enrolled if there has been no recurrence within 5 years); * Uncontrolled cardiovascular or cerebrovascular diseases with clinical symptoms, including but not limited to: ① NYHA class III or higher heart failure; ② unstable angina; ③ myocardial infarction or stroke within 6 months; ④ supraventricular or ventricular arrhythmias requiring treatment or intervention; ⑤ uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg despite optimal treatment); * Known active hepatitis B subjects (HBsAg positive and HBV DNA ≥ 10³ copies or ≥ 1000 U/ml); * Active infection or unexplained fever \> 38.5°C during the screening period or on the day of administration (subjects with fever caused by tumors can be enrolled as judged by the investigator), which, in the investigator\'s judgment, would affect the subject\'s participation in this trial or interfere with the evaluation of efficacy; * Pregnant or breastfeeding women; * Women of childbearing potential with a positive blood (urine) pregnancy test during the screening period (both male and female subjects should use reliable contraception during the trial and for 3 months after the last dose to prevent pregnancy); * Subjects with other medical or social issues that, in the investigator\'s judgment, might affect their ability to sign informed consent, participation in the trial, or interpretation of the trial results; * Patients with an estimated survival time of ≤ 3 months are not included in this study.
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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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Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 2000010, China
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