Adebrelimab Infusion Plus Standard Care for Pancreatic Cancer With Pleural or Peritoneal Effusions

NCT07230301 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DZQH-KYLLFS-25-19
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Study:
2. 2.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.
3. 3.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.
4. 4.What will happen if I join the study?
5. 5.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.
6. 6.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.
7. 7.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.
8. 8.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.
9. 9.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.

Conditions

Pancreatic Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Time from first dose until death from any cause.

  From first dose until death, assessed up to 36 months

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  From first dose until disease progression or death, assessed up to 36 months

• Progression-Free Survival (PFS)

  From first dose until disease progression or death, assessed up to 36 months

• Disease Control Rate (DCR)

  From first dose until disease progression, death, or last tumor assessment, assessed up to 36 months

• Puncture-Free Survival

  From last dose until re-drainage of effusion or death, assessed up to 36 months

• Effusion Control Rate

  From first dose, assessed every 3 weeks until disease progression or death, up to 36 months

Study Arms (1)

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.

Drug: Adebrelimab (PD-L1 inhibitor)

Interventions

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.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sizhen Wang: lead

MeSH Terms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician / Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: November 17, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 17, 2025

Record last verified: 2025-11