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Malignant AscitesPhase 1/2NCT05501340

PD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant Ascites

A Phase 1/2 study testing Serplulimab, Molgramostim and Hypofractionated radiotherapy/Sterotactic body radiotherapy in people with Malignant Ascites, run by Second Affiliated Hospital of Soochow University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The effect and safety of intraperitoneal infusion of PD-1 inhibitor is unclear for patients with peritoneal metastasis of advanced malignant tumors and malignant ascites. It is planned to determine the safety and efficacy of intraperitoneal infusion of PD-1 inhibitor combination with PRaG therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Ascites
What is being tested?
Serplulimab, Molgramostim and Hypofractionated radiotherapy/Sterotactic body radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Sep 2022to 1 Sep 2024
Phase
Phase 1/2
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

  • Patients > 18 years of age.
  • Pathologically diagnosed malignant tumor abdominal metastasis with malignant ascites (or ascites exfoliative cytology confirmed malignant peritoneal effusion), without brain metastasis or liver metastasis. The patient had newly diagnosed abdominal metastasis with malignant ascites for no more than 1 month.
  • Progression on at least one line of prior standard therapy or unsuitability for standard systemic therapy.
  • No congestive heart failure, unstable angina pectoris, unstable arrhythmia within the past 6 months.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-3, and life expectancy 2 months or more.
  • No previous severe hematopoietic function, heart, lung, liver, kidney dysfunction and immunodeficiency.
  • One week before enrollment, the absolute value of peripheral blood T total lymphocytes ≥ 0.5 times the lower limit of normal, the absolute number of CD8 + T cells ≥ 200/uL, neutrophils ≥ 1.0 × 109/L; AST and ALT ≤ 3.0 times the upper limit of normal; creatinine ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 50 mL/min, serum albumin ≥ 30 g/L. After treatment, the indicators are allowed to reach the above criteria and last for 2 weeks. Transfusion therapy or granulocyte stimulating factor therapy is not allowed before treatment.
  • Patients must have the ability to understand and voluntarily sign an informed consent form.

Who cannot join

  • Pregnant or lactating women.
  • Patients with a history of other malignant diseases in the last 2 years, except cured skin cancer and carcinoma in situ.
  • Patients with a history of uncontrolled epilepsy, central nervous system diseases or mental disorders, whose clinical severity may hinder the signing of informed consent or affect the patient's compliance with drug treatment as judged by the investigator.
  • Clinically significant (ie, active) heart disease, such as symptomatic coronary heart disease, congestive heart failure New York Heart Association (NYHA) Class II or greater, or severe arrhythmia requiring drug intervention, or a history of myocardial infarction within the last 12 months.
  • Organ transplantation requiring immunosuppressive therapy.
  • Known active infection, or significant hematological, renal, metabolic, gastrointestinal, endocrine function or metabolic disorders, or other serious uncontrolled concomitant diseases as judged by the investigator.
Show all 12Show fewer
  • Hypersensitivity to any component of the study drug.
  • History of immunodeficiency, including positive HIV test or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation, or other related diseases requiring long-term oral hormone therapy (greater than 10 mg/d prednisone).
  • Patients who are in the period of acute and chronic tuberculosis infection (patients with positive T-spot test and suspicious tuberculosis lesions on chest radiography), are in the period of acute hepatitis infection or have chronic hepatitis B virus copy number higher than the normal range.
  • There are contraindications for abdominal paracentesis, including coagulation dysfunction such as severe thrombocytopenia, severe intestinal dilatation and enteroparalysis, and peritoneal adhesion.
  • Patients previously treated with immune checkpoint inhibitors and discontinued due to drug-related toxicity.
  • Other conditions considered unsuitable by the investigator.

Trial locations and contacts

No sites are listed yet.

Yuehong Kong, Doctor contact

+8613375183257

kkyuehong@163.com

About this study

Official title: Phase I-II Clinical Study of PRaG（PD-1 Inhibitor Intravenous Injectio,Radiotherapy and GM-CSF）Combined With PD-1 Inhibitor Intraperitoneal Perfusion for Advanced Refractory Solid Tumors Combined With Malignant Ascites

The effect and safety of intraperitoneal infusion of PD-1 inhibitor is unclear for patients with peritoneal metastasis of advanced malignant tumors and malignant ascites. It is planned to determine the safety and efficacy of intraperitoneal infusion of PD-1 inhibitor combination with PRaG therapy.

Read the detailed description

Patinets with peritoneal metastasis have limited treatment and poor prognosis. Evidence has shown that there are T lymphocates and macrophages in the ascites microenviroment.We suggested the Intraperitoneal infusion of PD-1 inhibitor might activate T cells and produce anti-tumor effect.The intraperitoneal infusion of PD-1 inhibitorand combined with PRaG(Intravenous injectionof PD-1 inhibitor, Radiotherapy and GM-CSF）might benefit the survival of patients with peritoneal metastasis of advanced malignant tumors with malignant ascites. It is planned to determine the safety in phase I clinical trial. Further through phase II clinical trials, to clarify the effectiveness of this therapy.

Being tested
Serplulimab, Molgramostim, Hypofractionated radiotherapy/Sterotactic body radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SerplulimabDrug

    Also called HLX10

    PD-1 inhibitor (HLX10, serplulimab) 100mg intraperitoneal infusion every two weeks after radiotherapy PD-1 inhibitor (HLX10, serplulimab) 3mg/kg intravenous infusion within one week after radiotherapy every two weeks

  • MolgramostimDrug

    Also called rhGM-CSF

    200ug qd subcutaneous injection for 7 days

  • Hypofractionated radiotherapy/Sterotactic body radiotherapyRadiation

    8Gy*3f

Study groups in NCT05501340
Study groupRoleWhat they receive
PRaG combined PD-1 inhibitor intraperitoneal injectionExperimentalPRaG(PD-1 inhibitor,Radiotherapy and GM-CSF) combined with PD-1 inhibitor intraperitoneal injection
Receives: Drug: Serplulimab; Drug: Molgramostim; Radiation: Hypofractionated radiotherapy/Sterotactic body radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity（DLT）by CTCAE5.0

    CTCAE is widely accepted throughout the oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings

    Measured: 6 months (phase 1)

  2. Treatment Related Severe Adverse Effects

    Number of participants with treatment-related severe adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: 6 months (phase 1)

  3. OS

    overall survival time

    Measured: 12 months (phase 2)

Secondary outcomes (3)

  1. OS

    overall survival time

    Measured: 12 months (phase 1)

  2. PFS

    progression-free survival

    Measured: 12 months (phase 1/2)

  3. ascites control rate

    ascites control rate

    Measured: 12 months(phase 1/2 )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Intraperitoneal infusion of PD-1 inhibitor can produce anti-tumor effect, and intraperitoneal infusion of PD-1 inhibitor combined with PRaG（Radiotherapy and GM-CSF）can benefit the survival of patients with peritoneal metastasis of advanced malignant tumors and malignant ascites
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501340
Sponsor's protocol ID
JD-LK-2022-033-02
Status last verified
Aug 2022
First submitted
8 Aug 2022
Last updated
15 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Serplulimab, Molgramostim and Hypofractionated radiotherapy/Sterotactic body radiotherapy in people with Malignant Ascites, run by Second Affiliated Hospital of Soochow University.

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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 15 Aug 2022. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuehong Kong, Doctor (+8613375183257, kkyuehong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity（DLT）by CTCAE5.0 (time frame: 6 months (phase 1)). The study lists 3 primary outcomes in all. 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 NCT05501340.

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 15 Aug 2022.

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