Malignant AscitesNCT05745233
Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites
A study testing Nivolumab and Pembrolizumab in people with Malignant Ascites, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This projectis aim to evaluate the efficacy of immune checkpoint inhibitor (pembrolizumab or nivolumab) on the malignant ascites of patients with advanced gastric, pancreatic and biliary tract cancers. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Malignant Ascites
- What is being tested?
- Nivolumab and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to Dec 2026
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have cyto-/histologically confirmed malignant ascites from gastric, pancreatic or biliary tract adenocarcinoma
- Patients have malignant ascites more than 1000ml
- Patients have no history of prior intraperitoneal therapy for malignant ascites
- Patients have life expectancy of at least 4 weeks
- Patients have adequate platelet count ≥ 50,000/ul
- Women or men of reproductive potential should agree to use an effective contraceptive method
- All patients must be informed of the investigational nature of this study and must sign written informed consents.
Who cannot join
- Patients have ascites which is related to causes other than the malignancies
- Patients who are receiving intraperitoneal treatment for their malignant ascites including therapeutic paracentesis
- Patients with active infection
- Patients with bleeding disorders
- Patient with active cardiopulmonary disease or history of ischemic heart disease
- Patients have intolerant abdominal pain
- Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Intraperitoneal Immune Checkpoint Inhibitor on Malignant Ascites of Patients With Gastric, Pancreatic or Biliary Tract Cancer
This projectis aim to evaluate the efficacy of immune checkpoint inhibitor (pembrolizumab or nivolumab) on the malignant ascites of patients with advanced gastric, pancreatic and biliary tract cancers.
Read the detailed description
Malignant ascites appear when cancer cells metastasize to peritoneal cavity and interfere the circulation of lymph and blood. Patients with malignant ascites suffer from abdominal fullness, abdominal pain, poor intake, decreased nutrition, disability, and eventually inability to further anticancer treatment. Malignant ascites put a heavy burden on patient, their family, society and health care system.
Malignant ascites from cancers of stomach, pancreas and biliary tract are more refractory to intravenous chemotherapy or intraperitoneal chemotherapy than ascites from ovarian or chemo-naïve colorectal cancers because of the inherent nature of chemoresistance. Paracentesis is a treatment with immediate effect but the ascites regrow rapidly and repetitive paracentesis puts patients on the risk of intraabdominal infection. Intraperitoneal infusion of OK-432 can reduce malignant ascites but with intolerable adverse effects of fever, chills, pain, vomiting and septation of ascites which limit the further paracentesis.
Cumulating clinical experience suggests a tolerable safety profile of immune checkpoint inhibitors compared to chemotherapy for patients with malignancy. One theoretical advantage of intraperitoneal administration of immune checkpoint inhibitors is the existence of abundant inflammatory cells, immune cells and mesothelial cells dispersed in the malignant ascites. In addition, both pembrolizumab and nivolumab have been administrated intraperitoneally without obvious toxicities in murine tumor models At China Medical University Hospital, one hundred gastric cancer patients, 50 pancreatic cancer patients and 50 biliary tract cancer patients are registered and treated each year. Among them, more than 20 patients suffer from malignant ascites which will ultimately be managed by repeated paracentesis with increasing frequency. Till now, there is no reported or ongoing clinical trial to investigate the efficacy of intraperitoneal checkpoint inhibitor on the malignant ascites.
- Conditions
- Malignant Ascites
- Being tested
- Nivolumab, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Intraperitoneal administration of nivolumab Nivolumab 20 mg in normal saline 100ml will be infused intraperitoneally through a temporary catheter in 10 minutes after paracentesis in a weekly interval.
PembrolizumabDrug
Also called Keytruda
Intraperitoneal administration of pembrolizumab Pembrolizumab 20 mg in normal saline 100ml will be infused intraperitoneally through a temporary catheter in 10 minutes after paracentesis in a weekly interval.
| Study group | Role | What they receive |
|---|---|---|
| Checkpoint inhibitor (nivolumab or pembrolizumab) | Experimental | Patients with malignant ascites will received either nivolumab or pembrolizumab intraperitoneally. Receives: Drug: Nivolumab; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Control of ascites Rate of ascites control = number of patients who have less ascites determinded by five-point method and subjective symptoms / all patients
Measured: From the date of registration until the end of treatment, up to 2 years.
Secondary outcomes (1)
Adverse effects
Adverse effect of intraperitoneal immune checkpoint inhibitor Incidence of adverse effect = number of patients who develop a kind of adverse effect / all patients
Measured: From the date of registration until treatment termination, 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 posted27 Feb 2023
- Study start1 Jan 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant AscitesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Yuan Bai, China Medical University Hospital
- Investigators
- Li-Yuan Bai, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745233
- Sponsor's protocol ID
- CMUH107-REC1-180
- Status last verified
- Aug 2023
- First submitted
- 16 Feb 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang ST, Chiu CF, Bai HJ, Bai LY. Intraperitoneal nivolumab in a patient with pancreatic cancer and refractory malignant ascites. Eur J Cancer. 2021 May;148:48-50. doi: 10.1016/j.ejca.2021.01.045. Epub 2021 Mar 15. No abstract available.
PubMed 33735808Wang HT, Yu YL, Lo WJ, Lin MC, Chu CL, Chen CY, Wang ST, Chiu CF, Bai EJ, Bai LY. Intraperitoneal nivolumab for malignant ascites in patients with advanced gastrointestinal or pancreaticobiliary tract cancer. Int J Clin Oncol. 2026 Feb;31(2):281-291. doi: 10.1007/s10147-025-02930-y. Epub 2025 Dec 10.
PubMed 41369826
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraperitoneal Immune Checkpoint Inhibitor on Malignant Ascites of Patients With Gastric, Pancreatic or Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT05745233
- Acronym / sponsor ID
- CMUH107-REC1-180
- Conditions
- Malignant Ascites
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Feb 2023 (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 projectis aim to evaluate the efficacy of immune checkpoint inhibitor (pembrolizumab or nivolumab) on the malignant ascites of patients with advanced gastric, pancreatic and biliary tract cancers.
Detailed description
Malignant ascites appear when cancer cells metastasize to peritoneal cavity and interfere the circulation of lymph and blood. Patients with malignant ascites suffer from abdominal fullness, abdominal pain, poor intake, decreased nutrition, disability, and eventually inability to further anticancer treatment. Malignant ascites put a heavy burden on patient, their family, society and health care system.
Malignant ascites from cancers of stomach, pancreas and biliary tract are more refractory to intravenous chemotherapy or intraperitoneal chemotherapy than ascites from ovarian or chemo-naïve colorectal cancers because of the inherent nature of chemoresistance. Paracentesis is a treatment with immediate effect but the ascites regrow rapidly and repetitive paracentesis puts patients on the risk of intraabdominal infection. Intraperitoneal infusion of OK-432 can reduce malignant ascites but with intolerable adverse effects of fever, chills, pain, vomiting and septation of ascites which limit the further paracentesis.
Cumulating clinical experience suggests a tolerable safety profile of immune checkpoint inhibitors compared to chemotherapy for patients with malignancy. One theoretical advantage of intraperitoneal administration of immune checkpoint inhibitors is the existence of abundant inflammatory cells, immune cells and mesothelial cells dispersed in the malignant ascites. In addition, both pembrolizumab and nivolumab have been administrated intraperitoneally without obvious toxicities in murine tumor models At China Medical University Hospital, one hundred gastric cancer patients, 50 pancreatic cancer patients and 50 biliary tract cancer patients are registered and treated each year. Among them, more than 20 patients suffer from malignant ascites which will ultimately be managed by repeated paracentesis with increasing frequency. Till now, there is no reported or ongoing clinical trial to investigate the efficacy of intraperitoneal checkpoint inhibitor on the malignant ascites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Checkpoint inhibitor (nivolumab or pembrolizumab) | Experimental | Drug: Nivolumab, Drug: PembrolizumabPatients with malignant ascites will received either nivolumab or pembrolizumab intraperitoneally. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients have cyto-/histologically confirmed malignant ascites from gastric, pancreatic or biliary tract adenocarcinoma
- Patients have malignant ascites more than 1000ml
- Patients have no history of prior intraperitoneal therapy for malignant ascites
- Patients have life expectancy of at least 4 weeks
- Patients have adequate platelet count ≥ 50,000/ul
Key exclusion criteria (7 listed)
- Patients have ascites which is related to causes other than the malignancies
- Patients who are receiving intraperitoneal treatment for their malignant ascites including therapeutic paracentesis
- Patients with active infection
- Patients with bleeding disorders
- Patient with active cardiopulmonary disease or history of ischemic heart disease
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 |
|---|---|---|
| NivolumabAlso: OpdivoIntraperitoneal administration of nivolumab Nivolumab 20 mg in normal saline 100ml will be infused intraperitoneally through a temporary catheter in 10 minutes after paracentesis in a weekly interval. | Drug | Checkpoint inhibitor (nivolumab or pembrolizumab) |
| PembrolizumabAlso: KeytrudaIntraperitoneal administration of pembrolizumab Pembrolizumab 20 mg in normal saline 100ml will be infused intraperitoneally through a temporary catheter in 10 minutes after paracentesis in a weekly interval. | Drug | Checkpoint inhibitor (nivolumab or pembrolizumab) |
Primary outcome
Response rate
Time frame: From the date of registration until the end of treatment, up to 2 years.
Control of ascites Rate of ascites control = number of patients who have less ascites determinded by five-point method and subjective symptoms / all patients
1 secondary outcome
Adverse effects
Time frame: From the date of registration until treatment termination, 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 24 Aug 2023.
- Background: PubMed 33735808Wang ST, Chiu CF, Bai HJ, Bai LY. Intraperitoneal nivolumab in a patient with pancreatic cancer and refractory malignant ascites. Eur J Cancer. 2021 May;148:48-50. doi: 10.1016/j.ejca.2021.01.045. Epub 2021 Mar 15. No abstract available.
- Derived from this study: PubMed 41369826Wang HT, Yu YL, Lo WJ, Lin MC, Chu CL, Chen CY, Wang ST, Chiu CF, Bai EJ, Bai LY. Intraperitoneal nivolumab for malignant ascites in patients with advanced gastrointestinal or pancreaticobiliary tract cancer. Int J Clin Oncol. 2026 Feb;31(2):281-291. doi: 10.1007/s10147-025-02930-y. Epub 2025 Dec 10.
- 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.
Li-Yuan Bai principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nivolumab and Pembrolizumab in people with Malignant Ascites, run by China Medical University Hospital at 1 site in Taiwan.
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 7 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: enrolling by invitation, as of the sponsor's last update on 24 Aug 2023. 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 Taiwan. 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.
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?
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?
Response rate (time frame: From the date of registration until the end of treatment, up to 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745233, which also lists 2 linked publications.
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 24 Aug 2023.