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New treatment option for Pancreatic Neoplasms
Official title Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhibitors for Pancreatic Cancer Liver Metastases
ClinicalTrials.gov ID: NCT07504471
What this study is testing
What is pH-NASOX-Immune Group?
pH-NASOX-Immune Group is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pancreatic neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase II clinical study evaluates the safety and efficacy of a combination therapy for patients with pancreatic cancer that has spread to the liver. Because liver metastases are a major factor in the progression of pancreatic cancer, this research utilizes Hepatic Arterial Infusion Chemotherapy (HAIC) to deliver high-concentration treatment directly into the tumor's blood supply.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
- Neutrophils ≥ 1.5 × 10⁹ /L;
You likely can't join if
- people with ascites requiring clinical intervention (including moderate to large amounts of ascites; people with ascites need to be stable for more...
- 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; people with other previous tumors...
- Uncontrolled cardiovascular or cerebrovascular diseases with clinical symptoms, including but not limited to: ① NYHA class III or higher heart...
- Known active hepatitis B people (HBsAg positive and HBV DNA ≥ 10³ copies or ≥ 1000 U/ml);
See the full eligibility 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:
- Neutrophils ≥ 1.5 × 10⁹ /L;
- White blood cells ≥ 3.0 × 10⁹ /L;
- Platelets ≥ 85 × 10⁹ /L;
- Hemoglobin ≥ 70 g/L; b. Biochemical tests:
- Total bilirubin ≤ 2× upper limit of normal (ULN) (for people with biliary obstruction, after biliary drainage ≤ 2.5 × ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic people ≤ 5 × ULN;
- Albumin level ≥ 28 g/L;
- Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:
- Normal electrocardiogram (ECG) or ECG abnormalities deemed clinically insignificant by the investigator;
- 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.
- people with ascites requiring clinical intervention (including moderate to large amounts of ascites; people 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; people 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...
- Known active hepatitis B people (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 (people with fever caused by tumors can be enrolled as judged by the investigator), which, in the...
- Pregnant or breastfeeding women;
- Women of childbearing potential with a positive blood (urine) pregnancy test during the screening period (both male and female people should use reliable contraception during the trial and for 3 months after the last...
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.