Pancreatic NeoplasmsPhase 2NCT07504471
Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen and Programmed Death-1 (PD-1) Inhibitors for Pancreatic Cancer Liver Metastases
A Phase 2 study testing pH-NASOX-Immune Group in people with Pancreatic Neoplasms and Hepatic Metastasis of Pancreatic Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Hepatic Metastasis of Pancreatic Cancer
- What is being tested?
- pH-NASOX-Immune Group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2026to 31 Dec 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Hematological tests:
- Neutrophils ≥ 1.5 × 10⁹ /L;
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- White blood cells ≥ 3.0 × 10⁹ /L;
- Platelets ≥ 85 × 10⁹ /L;
- Hemoglobin ≥ 70 g/L; b. Biochemical tests:
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- Total bilirubin ≤ 2× upper limit of normal (ULN) (for subjects with biliary obstruction, after biliary drainage ≤ 2.5 × ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in metastatic subjects ≤ 5 × ULN;
- Albumin level ≥ 28 g/L;
- Creatinine clearance rate ≥ 60 ml/min; c. Cardiac function tests:
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- 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.
Who cannot join
- 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);
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- 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.
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
Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 2000010
Zhongmin Wang, 13901848333, wzm11896@rjh.com.cn
Xiaoyu Liu, 15121013042, lxy12931@rjh.com.cn
About this study
Official title: A Prospective, Single-Center, Phase II Clinical Study of Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen (Liposomal Irinotecan, Oxaliplatin, and S-1) Hepatic Arterial Infusion Chemotherapy (HAIC) and Intra-Arterial Programmed Death-1 (PD-1) Inhibitors for Liver Metastases From Pancreatic Cancer
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. The multi-step strategy involves first infusing Sodium Bicarbonate to neutralize the acidic tumor microenvironment , followed by the NASOX chemotherapy regimen (Oxaliplatin and Liposomal Irinotecan) and an intra-arterial PD-1 inhibitor to boost immune response. Patients also receive oral S-1 to maintain treatment effect. The primary goal is to determine if this integrated approach can improve Overall Survival for patients compared to historical standard treatments.
- Being tested
- pH-NASOX-Immune Group
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pH-NASOX-Immune GroupDrug
Patients receive a combination treatment in 21-day cycles. On Day 1 of each cycle, an interventional procedure is performed via femoral artery catheterization to the hepatic artery, beginning with a pre-treatment of 50-100 mL of 5% Sodium Bicarbonate (NaHCO3) followed by a 5% glucose flush to modulate the tumor microenvironment. This is immediately followed by the NASOX-HAIC regimen, consisting of a 2-hour hepatic arterial infusion of Oxaliplatin (85 mg/m²) and an infusion of Liposomal Irinotecan (70 mg/m²). Before the catheter is removed, a fixed 200 mg dose of a PD-1 inhibitor (Sintilimab, Tislelizumab, or Toripalimab) is administered via intra-arterial injection. To complete the cycle, patients take oral S-1 twice daily from Day 1 to Day 14 (with the dose determined by body surface area), followed by a 7-day rest period.
| Study group | Role | What they receive |
|---|---|---|
| Interventional THERAPY Group | Experimental | Not described Receives: Drug: pH-NASOX-Immune Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: From the date of first treatment until the date of death from any cause, assessed up to 2 years.
Secondary outcomes (2)
Progression-Free Survival (PFS)
Measured: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Objective Response Rate (ORR)
Measured: From enrollment until the date of first documented progression, assessed up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongmin Wang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504471
- Sponsor's protocol ID
- 2026-64
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Phase II Clinical Study of Hepatic Arterial Infusion of Sodium Bicarbonate (NaHCO3) Combined With NASOX Regimen (Liposomal Irinotecan, Oxaliplatin, and S-1) Hepatic Arterial Infusion Chemotherapy (HAIC) and Intra-Arterial Programmed Death-1 (PD-1) Inhibitors for Liver Metastases From Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07504471
- Acronym / sponsor ID
- 2026-64
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Mar 2026 (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.
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. The multi-step strategy involves first infusing Sodium Bicarbonate to neutralize the acidic tumor microenvironment , followed by the NASOX chemotherapy regimen (Oxaliplatin and Liposomal Irinotecan) and an intra-arterial PD-1 inhibitor to boost immune response. Patients also receive oral S-1 to maintain treatment effect. The primary goal is to determine if this integrated approach can improve Overall Survival for patients compared to historical standard treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional THERAPY Group | Experimental | Drug: pH-NASOX-Immune Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- <!-- -->
Key exclusion criteria (11 listed)
- 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);
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 |
|---|---|---|
| pH-NASOX-Immune GroupPatients receive a combination treatment in 21-day cycles. On Day 1 of each cycle, an interventional procedure is performed via femoral artery catheterization to the hepatic artery, beginning with a pre-treatment of 50-100 mL of 5% Sodium Bicarbonate (NaHCO3) followed by a 5% glucose flush to modulate the tumor microenvironment. This is immediately followed by the NASOX-HAIC regimen, consisting of a 2-hour hepatic arterial infusion of Oxaliplatin (85 mg/m²) and an infusion of Liposomal Irinotecan (70 mg/m²). Before the catheter is removed, a fixed 200 mg dose of a PD-1 inhibitor (Sintilimab, Tislelizumab, or Toripalimab) is administered via intra-arterial injection. To complete the cycle, patients take oral S-1 twice daily from Day 1 to Day 14 (with the dose determined by body surface area), followed by a 7-day rest period. | Drug | Interventional THERAPY Group |
Primary outcome
Overall Survival (OS)
Time frame: From the date of first treatment until the date of death from any cause, assessed up to 2 years.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
Objective Response Rate (ORR)
Time frame: From enrollment until the date of first documented progression, assessed up to 2 years.
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 31 Mar 2026.
- 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 Phase 2 study testing pH-NASOX-Immune Group in people with Pancreatic Neoplasms and Hepatic Metastasis of Pancreatic Cancer, run by Ruijin Hospital 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 20 inclusion and 11 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 31 Mar 2026. 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?
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 Zhongmin Wang (13901848333, wzm11896@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From the date of first treatment until the date of death from any cause, assessed up to 2 years.). 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 31 Mar 2026.