Hyperthermic Intraperitoneal ChemotherapyPhase 2NCT06946901
The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial
A Phase 2 study testing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy in people with Hyperthermic Intraperitoneal Chemotherapy and Peritoneal Metastatic Pancreatic Cancer, run by Shanghai Zhongshan Hospital at 2 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness and safety of hyperthermic intraperitoneal chemotherapy combined with intravenous chemotherapy in peritoneal metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperthermic Intraperitoneal Chemotherapy, Peritoneal Metastatic Pancreatic Cancer
- What is being tested?
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 3 Apr 2025to 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtain signed informed consent from the patient or their legal representative, with adherence to the study protocol and follow-up procedures;
- Aged >=18 and <=80 years, regardless of gender;
- No contraindications to surgery, with an ECOG performance status of 0-1;
- Confirmed peritoneal metastasis by imaging or intraoperative detection, with rapid intraoperative histopathology indicating metastatic adenocarcinoma;
- No prior anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-intensity focused ultrasound (HIFU), radiotherapy, immunotherapy, molecular targeted therapy, or traditional Chinese medicine anti-tumor treatments;
- No severe hematological, cardiac, pulmonary dysfunction, or autoimmune deficiency (based on respective diagnostic criteria);
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- Hematological criteria: White blood cells (WBC) >=3.0 × 10⁹/L; Absolute neutrophil count (ANC) >=1.5 × 10⁹/L; Platelets (PLT) >=100 × 10⁹/L; Hemoglobin (Hgb) >=90 g/L.
- Blood biochemistry criteria: AST (SGOT) and ALT (SGPT) <=2.5 × upper limit of normal (ULN); Total bilirubin (TBIL) <=2 × ULN; Serum creatinine (CRE) <=1.5 × ULN.
- Coagulation function: Prothrombin time (PT) and international normalized ratio (INR) <=1.5 × ULN;
- Compliance with study visit schedules and other protocol requirements.
Who cannot join
- Presence of distant metastases to other organs (e.g., liver, bone, lung) with definitive evidence, except for ovarian metastases;
- History of other systemic malignancies within the past five years;
- Use of any non-anti-tumor investigational drugs within 4 weeks prior to treatment;
- Accompanied by massive ascites (extending from pelvic to upper abdominal cavity);
- History of upper gastrointestinal bleeding requiring repeated blood transfusions within the past three months;
- Pregnancy, autoimmune diseases, severe hyperthyroidism/hypothyroidism, central nervous system disorders, psychiatric illnesses, unstable angina, congestive heart failure, severe arrhythmias, or other uncontrolled serious medical conditions;
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- History of hypersensitivity to the study drugs or medications with similar chemical structures;
- Patients requiring long-term warfarin anticoagulation therapy;
- Poor compliance, inability or unwillingness to provide signed informed consent;
- Patients likely to be lost to follow-up for ≥14 days during the treatment period.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Wei Liu, Dr, 86 18321789939
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Wenquan Wang, Dr, 8613701874954, Wang.wenquan@zs-hospital.sh.cn
Liang Liu, Dr
About this study
The goal of this clinical trial is to evaluate the effectiveness and safety of hyperthermic intraperitoneal chemotherapy combined with intravenous chemotherapy in peritoneal metastatic pancreatic cancer. The main question it aims to answer are:
(1) Does this combined approach increase 1-year survival rates? and (2) What is the safety profile of this treatment regimen?
Read more
Participants will:
undergo baseline imaging and surgical exploration to confirm peritoneal metastasis, receive two cycles of intraperitoneal cisplatin HIPEC (70mg/m²) postoperatively, followed by systemic AG chemotherapy (nab-paclitaxel plus gemcitabine), with treatment adjustments based on regular imaging assessments and multidisciplinary team (MDT) recommendations.
- Being tested
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG ChemotherapyCombination product
- HIPEC (cisplatin 70mg/m², Day 1,3 post-surgery), 1 cycle；
- Systemic AG chemotherapy (nab-paclitaxel 125mg/m²+ gemcitabine 1000mg/m², initiated, Day 1,8,15, q4 week), 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| HIPEC + AG Chemotherapy Group | Experimental | Not described Receives: Combination Product: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Overall Survival (OS) Rate
The proportion of patients alive at 12 months after initiation of the combined HIPEC and systemic AG chemotherapy treatment, analyzed by Kaplan-Meier method.
Measured: From enrollment to 12 months post-treatment initiation
Secondary outcomes (3)
Progression-free survival (PFS)
Time from treatment initiation to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first, assessed by blinded independent central review (BICR).
Measured: From enrollment until first documented progression or death (up to 24 months)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria during the study intervention period.
Measured: From enrollment until end of treatment (up to 12 months)
Safety and Tolerability (CTCAE v5.0)
Frequency and severity of adverse events (AEs), serious AEs (SAEs), and treatment discontinuations due to AEs, graded by CTCAE v5.0
Measured: From first HIPEC cycle to 30 days after last treatment (up to 13 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start3 Apr 2025
- Primary completion3 Apr 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 Hyperthermic Intraperitoneal ChemotherapyStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946901
- Sponsor's protocol ID
- ZSPAC-09
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Hyperthermic Intraperitoneal Chemotherapy Combined With Intravenous Chemotherapy for Peritoneal Metastatic Pancreatic Cancer, a Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06946901
- Acronym / sponsor ID
- ZSPAC-09
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 3 Apr 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Apr 2025 (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.
The goal of this clinical trial is to evaluate the effectiveness and safety of hyperthermic intraperitoneal chemotherapy combined with intravenous chemotherapy in peritoneal metastatic pancreatic cancer. The main question it aims to answer are:
(1) Does this combined approach increase 1-year survival rates? and (2) What is the safety profile of this treatment regimen?
Participants will:
undergo baseline imaging and surgical exploration to confirm peritoneal metastasis, receive two cycles of intraperitoneal cisplatin HIPEC (70mg/m²) postoperatively, followed by systemic AG chemotherapy (nab-paclitaxel plus gemcitabine), with treatment adjustments based on regular imaging assessments and multidisciplinary team (MDT) recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC + AG Chemotherapy Group | Experimental | Combination Product: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Obtain signed informed consent from the patient or their legal representative, with adherence to the study protocol and follow-up procedures;
- Aged >=18 and <=80 years, regardless of gender;
- No contraindications to surgery, with an ECOG performance status of 0-1;
- Confirmed peritoneal metastasis by imaging or intraoperative detection, with rapid intraoperative histopathology indicating metastatic adenocarcinoma;
- No prior anti-tumor therapy before treatment, including systemic chemotherapy, interventional chemotherapy, high-intensity focused ultrasound (HIFU), radiotherapy, immunotherapy, molecular targeted therapy, or traditional Chinese medicine anti-tumor treatments;
Key exclusion criteria (10 listed)
- Presence of distant metastases to other organs (e.g., liver, bone, lung) with definitive evidence, except for ovarian metastases;
- History of other systemic malignancies within the past five years;
- Use of any non-anti-tumor investigational drugs within 4 weeks prior to treatment;
- Accompanied by massive ascites (extending from pelvic to upper abdominal cavity);
- History of upper gastrointestinal bleeding requiring repeated blood transfusions within the past three months;
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 |
|---|---|---|
| Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy* HIPEC (cisplatin 70mg/m², Day 1,3 post-surgery), 1 cycle； * Systemic AG chemotherapy (nab-paclitaxel 125mg/m²+ gemcitabine 1000mg/m², initiated, Day 1,8,15, q4 week), 4 cycles | Combination product | HIPEC + AG Chemotherapy Group |
Primary outcome
1-year Overall Survival (OS) Rate
Time frame: From enrollment to 12 months post-treatment initiation
The proportion of patients alive at 12 months after initiation of the combined HIPEC and systemic AG chemotherapy treatment, analyzed by Kaplan-Meier method.
3 secondary outcomes
Progression-free survival (PFS)
Time frame: From enrollment until first documented progression or death (up to 24 months)
Objective Response Rate (ORR)
Time frame: From enrollment until end of treatment (up to 12 months)
Safety and Tolerability (CTCAE v5.0)
Time frame: From first HIPEC cycle to 30 days after last treatment (up to 13 months)
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 27 Apr 2025.
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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.
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 Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy in people with Hyperthermic Intraperitoneal Chemotherapy and Peritoneal Metastatic Pancreatic Cancer, run by Shanghai Zhongshan Hospital 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 10 inclusion and 10 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 27 Apr 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?
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 Wenquan Wang, Dr (86 13701874954, wang.wenquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Overall Survival (OS) Rate (time frame: From enrollment to 12 months post-treatment initiation). 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 27 Apr 2025.