Pancreatic Cancer MetastaticPhase 2NCT07230301
Adebrelimab Infusion Plus Standard Care for Pancreatic Cancer With Pleural or Peritoneal Effusions
A Phase 2 study testing Adebrelimab (PD-L1 inhibitor) in people with Pancreatic Cancer Metastatic, run by Sizhen Wang.
Trial summary
1. Study: A Clinical Study of Intra-cavity Adebrelimab Combined with Best Supportive Care for Pancreatic Cancer Patients with Pleural or Peritoneal Effusion (Malignant Ascites) 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer Metastatic
- What is being tested?
- Adebrelimab (PD-L1 inhibitor)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2025to 30 Jun 2028
- 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
- Age ≥ 18 years.
- Histologically or cytologically confirmed pancreatic cancer.
- Presence of malignant pleural or peritoneal effusion (≥4 cm) confirmed by pathology or cytology, requiring clinical intervention.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status 0-3.
- Estimated life expectancy ≥ 2 months.
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- Adequate organ function:
- Hemoglobin ≥ 80 g/L
- ANC ≥ 1.0 × 10⁹/L
- Platelets ≥ 50 × 10⁹/L
- TBIL < 3 × ULN
- ALT/AST < 5 × ULN
- Serum creatinine ≤ 1.25 × ULN or creatinine clearance > 45 mL/min
- Chronic HBV infection must be controlled with antiviral therapy and HBV DNA < 10,000 IU/mL.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for at least 8 weeks after the last dose; men must agree to contraception or have undergone sterilization.
- Voluntarily signed informed consent with good compliance for follow-up.
Who cannot join
- Asymptomatic effusion not requiring intervention.
- Contraindication to paracentesis or drainage.
- Contraindications to immunotherapy (e.g., chronic steroid use, prior immune-related pneumonitis, hepatitis, or colitis).
- Active autoimmune disease requiring systemic therapy.
- Active HCV, HIV, syphilis, or tuberculosis infection; uncontrolled severe infection within 4 weeks prior to first dose.
- History of allogeneic organ transplantation or autologous stem cell transplantation.
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- Severe pulmonary disease (e.g., pulmonary fibrosis, interstitial lung disease, pneumoconiosis).
- History of psychiatric illness or substance abuse affecting compliance.
- Participation in another interventional clinical trial within 4 weeks.
- Prior treatment with PD-1/PD-L1 antibodies via intrapleural or intraperitoneal route.
- Uncontrolled CNS metastases or intracranial hypertension.
- Active bleeding tendency, GI bleeding within 4 weeks, or ongoing anticoagulation/thrombolysis therapy.
- Other active malignancies (except cured basal cell carcinoma, cervical carcinoma in situ, or superficial bladder cancer).
- Pregnant or breastfeeding women.
- Any other condition judged by the investigator to affect participation or evaluation of the trial.
About this study
Official title: Intracavitary Infusion of Adebrelimab Combined With the Best Standard Treatment for the Treatment of Pancreatic Cancer With Pleural and Peritoneal Effusions: A Single-Center, Prospective, Clinical Trial
- Study: A Clinical Study of Intra-cavity Adebrelimab Combined with Best Supportive Care for Pancreatic Cancer Patients with Pleural or Peritoneal Effusion (Malignant Ascites)
- Why is this study being done? This study is being done to find out if a new approach to treatment is safe and effective for controlling malignant fluid buildup (pleural or peritoneal effusion) in the abdomen or chest in patients with pancreatic cancer. The approach involves putting a drug called Adebrelimab directly into the fluid cavity, in combination with the best available supportive care chosen by your doctor.
- What is Adebrelimab? Adebrelimab is a type of immunotherapy drug (a PD-L1 inhibitor) that helps the body's immune system fight cancer cells. It is already approved in China for treating some lung cancers. In this study, it is being given directly into the fluid buildup (intra-cavity) to see if it can work better there.
- What will happen if I join the study? Screening: First, you will go through tests to see if you are eligible. Treatment: If eligible, the fluid will be drained. Then, Adebrelimab will be infused into the cavity on Day 1 and Day 8 of each 3-week cycle. You will also receive the best supportive care for your cancer. Monitoring: You will have regular clinic visits for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects.
- How long will I be in the study? Treatment will continue as long as it is controlling the disease, you are not experiencing unacceptable side effects, and you choose to remain in the study.
- What are the potential benefits? You may experience a reduction in the cancer-related fluid buildup and better control of your cancer. However, benefit cannot be guaranteed. The information from this study may also help other patients in the future.
- What are the potential risks and side effects? Possible side effects of Adebrelimab include nausea, fatigue, decreased appetite, vomiting, diarrhea, low blood cell counts, and abnormal liver tests. There may also be unknown risks. The best supportive care has its own risks, which your doctor will explain. You will be monitored closely for safety.
- What are my other choices? You can choose not to participate. This will not affect your standard medical care. Your other options may include drainage of the fluid and other standard treatments aimed at managing your symptoms and cancer.
- Is participation voluntary? Yes. Your participation is completely voluntary. You can decide to leave the study at any time, for any reason, without any penalty or loss of benefits to which you are entitled.
Read the detailed description
Patients with pancreatic cancer and malignant pleural or peritoneal effusions first undergo screening, including imaging, laboratory tests, and confirmation of malignant effusion. After informed consent and baseline assessments, they receive intracavitary infusion of adebrelimab (600 mg on days 1 and 8 of each 3-week cycle), combined with the investigator's choice of best supportive treatment such as chemotherapy or targeted therapy. Even if effusion is markedly reduced or drainage becomes impossible, intracavitary administration is continued. Clinical monitoring involves regular vital signs, laboratory evaluations, and recording of adverse events according to NCI-CTCAE v5.0.
Efficacy is assessed by imaging every six weeks and ultrasound measurement of effusion volume, with treatment responses categorized as complete response, partial response, stable disease, or progression. The primary endpoint is overall survival, while secondary endpoints include objective response rate, progression-free survival, disease control rate, puncture-free survival, and effusion control rate. After the last dose, patients enter a 30-day safety follow-up, and then survival status is checked every 90 days until death or loss to follow-up.
- Conditions
- Pancreatic Cancer Metastatic
- Being tested
- Adebrelimab (PD-L1 inhibitor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab (PD-L1 inhibitor)Drug
Adebrelimab 600 mg administered by intrapleural or intraperitoneal infusion on Days 1 and 8 of each 3-week cycle (Q3W). Treatment is combined with investigator's choice of best supportive therapy, such as chemotherapy or targeted agents. Administration continues even if effusion decreases or becomes non-drainable.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Adebrelimab 600 mg administered intrapleurally or intraperitoneally on Days 1 and 8 of each 3-week cycle (Q3W), combined with investigator's choice of best supportive care (chemotherapy or targeted agents). Administration continues even if effusion decreases or becomes non-drainable. Receives: Drug: Adebrelimab (PD-L1 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from first dose until death from any cause.
Measured: From first dose until death, assessed up to 36 months
Secondary outcomes (6)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1.
Measured: From first dose until disease progression or death, assessed up to 36 months
Progression-Free Survival (PFS)
Time from the date of first dose of study treatment until the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: From first dose until disease progression or death, assessed up to 36 months
Disease Control Rate (DCR)
Proportion of patients achieving CR, PR, or stable disease (SD).
Measured: From first dose until disease progression, death, or last tumor assessment, assessed up to 36 months
Puncture-Free Survival
Time from last dose until the need for re-drainage of effusion or death.
Measured: From last dose until re-drainage of effusion or death, assessed up to 36 months
Effusion Control Rate
Proportion of patients with complete or partial control of malignant pleural/peritoneal effusion.
Measured: From first dose, assessed every 3 weeks until disease progression or death, up to 36 months
Safety and Tolerability
Incidence and severity of adverse events graded according to NCI-CTCAE v5.0.
Measured: From baseline through 90 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer MetastaticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, single-arm, prospective Phase II interventional study. All enrolled patients receive intracavitary infusion of adebrelimab combined with investigator's choice of best supportive treatment. The model is designed to evaluate safety and efficacy without a control arm.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sizhen Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sizhen Wang, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230301
- Sponsor's protocol ID
- DZQH-KYLLFS-25-19
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracavitary Infusion of Adebrelimab Combined With the Best Standard Treatment for the Treatment of Pancreatic Cancer With Pleural and Peritoneal Effusions: A Single-Center, Prospective, Clinical Trial
- ClinicalTrials.gov ID
- NCT07230301
- Acronym / sponsor ID
- DZQH-KYLLFS-25-19
- Conditions
- Pancreatic Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sizhen WangUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Nov 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.
- Study: A Clinical Study of Intra-cavity Adebrelimab Combined with Best Supportive Care for Pancreatic Cancer Patients with Pleural or Peritoneal Effusion (Malignant Ascites)
- Why is this study being done? This study is being done to find out if a new approach to treatment is safe and effective for controlling malignant fluid buildup (pleural or peritoneal effusion) in the abdomen or chest in patients with pancreatic cancer. The approach involves putting a drug called Adebrelimab directly into the fluid cavity, in combination with the best available supportive care chosen by your doctor.
- What is Adebrelimab? Adebrelimab is a type of immunotherapy drug (a PD-L1 inhibitor) that helps the body's immune system fight cancer cells. It is already approved in China for treating some lung cancers. In this study, it is being given directly into the fluid buildup (intra-cavity) to see if it can work better there.
- What will happen if I join the study? Screening: First, you will go through tests to see if you are eligible. Treatment: If eligible, the fluid will be drained. Then, Adebrelimab will be infused into the cavity on Day 1 and Day 8 of each 3-week cycle. You will also receive the best supportive care for your cancer. Monitoring: You will have regular clinic visits for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects.
- How long will I be in the study? Treatment will continue as long as it is controlling the disease, you are not experiencing unacceptable side effects, and you choose to remain in the study.
- What are the potential benefits? You may experience a reduction in the cancer-related fluid buildup and better control of your cancer. However, benefit cannot be guaranteed. The information from this study may also help other patients in the future.
- What are the potential risks and side effects? Possible side effects of Adebrelimab include nausea, fatigue, decreased appetite, vomiting, diarrhea, low blood cell counts, and abnormal liver tests. There may also be unknown risks. The best supportive care has its own risks, which your doctor will explain. You will be monitored closely for safety.
- What are my other choices? You can choose not to participate. This will not affect your standard medical care. Your other options may include drainage of the fluid and other standard treatments aimed at managing your symptoms and cancer.
- Is participation voluntary? Yes. Your participation is completely voluntary. You can decide to leave the study at any time, for any reason, without any penalty or loss of benefits to which you are entitled.
Detailed description
Patients with pancreatic cancer and malignant pleural or peritoneal effusions first undergo screening, including imaging, laboratory tests, and confirmation of malignant effusion. After informed consent and baseline assessments, they receive intracavitary infusion of adebrelimab (600 mg on days 1 and 8 of each 3-week cycle), combined with the investigator's choice of best supportive treatment such as chemotherapy or targeted therapy. Even if effusion is markedly reduced or drainage becomes impossible, intracavitary administration is continued. Clinical monitoring involves regular vital signs, laboratory evaluations, and recording of adverse events according to NCI-CTCAE v5.0.
Efficacy is assessed by imaging every six weeks and ultrasound measurement of effusion volume, with treatment responses categorized as complete response, partial response, stable disease, or progression. The primary endpoint is overall survival, while secondary endpoints include objective response rate, progression-free survival, disease control rate, puncture-free survival, and effusion control rate. After the last dose, patients enter a 30-day safety follow-up, and then survival status is checked every 90 days until death or loss to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, single-arm, prospective Phase II interventional study. All enrolled patients receive intracavitary infusion of adebrelimab combined with investigator's choice of best supportive treatment. The model is designed to evaluate safety and efficacy without a control arm.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Adebrelimab (PD-L1 inhibitor)Adebrelimab 600 mg administered intrapleurally or intraperitoneally on Days 1 and 8 of each 3-week cycle (Q3W), combined with investigator's choice of best supportive care (chemotherapy or targeted agents). Administration continues even if effusion decreases or becomes non-drainable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years.
- Histologically or cytologically confirmed pancreatic cancer.
- Presence of malignant pleural or peritoneal effusion (≥4 cm) confirmed by pathology or cytology, requiring clinical intervention.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status 0-3.
Key exclusion criteria (15 listed)
- Asymptomatic effusion not requiring intervention.
- Contraindication to paracentesis or drainage.
- Contraindications to immunotherapy (e.g., chronic steroid use, prior immune-related pneumonitis, hepatitis, or colitis).
- Active autoimmune disease requiring systemic therapy.
- Active HCV, HIV, syphilis, or tuberculosis infection; uncontrolled severe infection within 4 weeks prior to first dose.
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 |
|---|---|---|
| Adebrelimab (PD-L1 inhibitor)Adebrelimab 600 mg administered by intrapleural or intraperitoneal infusion on Days 1 and 8 of each 3-week cycle (Q3W). Treatment is combined with investigator's choice of best supportive therapy, such as chemotherapy or targeted agents. Administration continues even if effusion decreases or becomes non-drainable. | Drug | Experimental Arm |
Primary outcome
Overall Survival (OS)
Time frame: From first dose until death, assessed up to 36 months
Time from first dose until death from any cause.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first dose until disease progression or death, assessed up to 36 months
Progression-Free Survival (PFS)
Time frame: From first dose until disease progression or death, assessed up to 36 months
Disease Control Rate (DCR)
Time frame: From first dose until disease progression, death, or last tumor assessment, assessed up to 36 months
Puncture-Free Survival
Time frame: From last dose until re-drainage of effusion or death, assessed up to 36 months
Effusion Control Rate
Time frame: From first dose, assessed every 3 weeks until disease progression or death, up to 36 months
Safety and Tolerability
Time frame: From baseline through 90 days after the last dose of study treatment
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 17 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab (PD-L1 inhibitor) in people with Pancreatic Cancer Metastatic, run by Sizhen Wang.
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 16 inclusion and 15 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: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 (OS) (time frame: From first dose until death, assessed up to 36 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 17 Nov 2025.