Pancreatic NeoplasmPhase 2NCT05222204
DDP ip Combined With AG in PDAC With Peritoneal Metastasis
A Phase 2 study testing intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in people with Pancreatic Neoplasm, run by Fudan University at 2 sites in China.
Trial summary
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesChina
- Study dates
- 15 May 2022to 12 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- cohort A
- Patients should meet the following criteria before treatment to be included in the trial:
- Voluntarily participate and sign the informed consent;
- Age ≥18 years old and ≤75 years old, gender is not limited;
- ECOG score ≤2 points;
- Pathological diagnosis of pancreatic adenocarcinoma;
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- Advanced pancreatic cancer with intra-abdominal metastasis in imaging assessment, or intra-operative intra-operative findings of intra-abdominal metastasis;
- The time from the end of adjuvant chemotherapy after surgery is more than 6 months, or they have not received any form of anti-tumor therapy before, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;
- No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
- Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
- Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
- Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
- Able to comply with research visit plans and other protocol requirements.
- Patients should meet the following criteria before treatment to be included in the trial:
- Voluntarily participate and sign the informed consent;
- Age ≥18 years old and ≤75 years old, gender is not limited;
- ECOG score ≤2 points;
- Pathological diagnosis of pancreatic adenocarcinoma;
- malignant ascites with positive peritoneal cytology or Laparoscopic exploration processed.
- At least one systemic chemotherapy has been used;
- No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
- Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
- Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
- Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
- Able to comply with research visit plans and other protocol requirements.
Who cannot join
- Patients were excluded from the study if they met any of the following criteria:
- Associated with other systemic malignant tumors;
- Single kidney, deformed kidney or poor renal compensation;
- Have used any other study drug within 7 days before chemotherapy;
- Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
- There is a history of allergy to the study drug or drugs of similar structure;
- Patients who are using and require long-term use of warfarin anticoagulation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
- Conditions
- Pancreatic Neoplasm
- Being tested
- intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxelDrug
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
| Study group | Role | What they receive |
|---|---|---|
| IP | Experimental | intravenous AG+ IP cisplatin Receives: Drug: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
patients the time from enrollment to death from any cause
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start15 May 2022
- Primary completion8 Jul 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Model description
- two cohort: cohort A (first-line) and cohort B (post-line with malignant ascites )
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222204
- Sponsor's protocol ID
- CSPAC-38
- Status last verified
- May 2025
- First submitted
- 14 Sep 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: intravenous Gemcitabine+ Nab-paclitaxel combined with IP cisplatin in patients with PDAC with peritoneal metastasis
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis
- ClinicalTrials.gov ID
- NCT05222204
- Acronym / sponsor ID
- CSPAC-38
- Conditions
- Pancreatic Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 3 Feb 2022 (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.
intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- two cohort: cohort A (first-line) and cohort B (post-line with malignant ascites )
| Arm | Type | Receives |
|---|---|---|
| IP | Experimental | Drug: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxelintravenous AG+ IP cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- cohort A
- Voluntarily participate and sign the informed consent;
- Age ≥18 years old and ≤75 years old, gender is not limited;
- ECOG score ≤2 points;
- Pathological diagnosis of pancreatic adenocarcinoma;
Key exclusion criteria (7 listed)
- Associated with other systemic malignant tumors;
- Single kidney, deformed kidney or poor renal compensation;
- Have used any other study drug within 7 days before chemotherapy;
- Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
- There is a history of allergy to the study drug or drugs of similar structure;
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 (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxelintraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis | Drug | IP |
Primary outcome
overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
patients the time from enrollment to death from any cause
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Yes. intravenous Gemcitabine+ Nab-paclitaxel combined with IP cisplatin in patients with PDAC with peritoneal metastasis
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in people with Pancreatic Neoplasm, run by Fudan University at 2 sites 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 25 inclusion and 7 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: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). 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 22 May 2025.