Malignant AscitesPhase 1/2NCT07397819
Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy
A Phase 1/2 study testing liposomal irinotecan monotherapy, Liposomal Irinotecan + rmhTNF-NC and Liposomal Irinotecan + Bevacizumab in people with Malignant Ascites, run by Dong sheng Zhang at 1 site in China.
Trial summary
This study is a prospective, multi-cohort Phase Ib/II clinical trial, consisting of two stages as follows: 1. Phase Ib Dose-Escalation Stage To explore the dose-limiting toxicities (DLT) of intraperitoneally administered liposomal irinotecan in patients with malignant peritoneal effusion who have failed prior standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Ascites
- What is being tested?
- liposomal irinotecan monotherapy, Liposomal Irinotecan + rmhTNF-NC and Liposomal Irinotecan + Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2025to 30 Jun 2029
- Phase
- Phase 1/2
- 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
- Aged ≥18 years old, gender unrestricted.
- Histologically or cytologically confirmed malignant peritoneal effusion derived from digestive system tumors (malignancy confirmed by ascites cytology, or peritoneal metastases diagnosed clinically based on imaging findings and symptoms).
- Moderate to large volume of peritoneal effusion, with failure of initial treatment or previous intraperitoneal therapy with conventional chemotherapeutic agents and/or biological response modifiers. Moderate volume of ascites is defined as: ①Ascites depth ≥3 cm confirmed by supine abdominal ultrasound; ② Presence of clinical symptoms (chest distress, dyspnea, abdominal distension and discomfort) judged by the investigator to be related to peritoneal effusion.
- ECOG performance status score 0-2.
- Expected survival time >3 months.
- Essentially normal cardiopulmonary function.
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- Adequate organ function, with subjects required to meet the following laboratory parameters:
- Peripheral blood count: WBC ≥4.0×10⁹/L, PLT ≥80×10⁹/L, Hb ≥90 g/L.
- Renal function: Serum creatinine ≤2×ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥40 ml/min.
- Hepatic function: Total bilirubin ≤1.5×ULN; or total bilirubin >ULN with direct bilirubin ≤ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (for patients with liver metastases, ALT or AST ≤5×ULN is acceptable).
- Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.
- Thyroid stimulating hormone (TSH) ≤ULN. If TSH is abnormal, serum triiodothyronine (T3) and thyroxine (T4) levels, together with clinical manifestations, shall be evaluated comprehensively; subjects in non-acute active phase are eligible for enrollment.
- For non-surgically sterilized subjects of childbearing potential or female subjects of childbearing potential: A medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) must be used during the study treatment period and for 6 months after the end of study treatment. For non-surgically sterilized female subjects of childbearing potential, serum or urine HCG test must be negative within 7 days prior to enrollment, and they must be non-lactating. For male subjects whose partners are women of childbearing potential, effective contraceptive measures must be adopted during the trial and for 6 months after the last administration of the study drug.
- Voluntarily participate in the study with good compliance, sign a written informed consent form, and be able to cooperate with follow-up assessments.
Who cannot join
- History of hypersensitivity to tumor necrosis factor (TNF), its derivative drugs, bevacizumab or its analogs, irinotecan, or liposomal irinotecan.
- Diagnosis of malignant diseases other than gastrointestinal tumors within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ).
- Receipt of any other investigational drug treatment or participation in an interventional clinical trial within 7 days prior to the first dose; or receipt of anti-tumor therapy (including Chinese herbal medicines with anti-tumor indications) within 7 days prior to the first dose of the study drug.
- Pregnant or lactating women; women of childbearing potential who are unwilling to take contraceptive measures during the study period; or men who are unwilling to use effective contraceptive measures during treatment and for 1 year thereafter.
- Significant impairment of major organ function.
- Patients with obvious bleeding tendency.
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- Clinically significant or uncontrolled cardiac diseases, including unstable angina pectoris, acute myocardial infarction within 6 months prior to the first dose, New York Heart Association (NYHA) Class III/IV congestive heart failure, and uncontrolled arrhythmias (subjects with pacemakers or atrial fibrillation with well-controlled heart rate are permitted).
- Clinically significant ECG abnormalities or relevant medical history as judged by the investigator; screening QTcF interval > 480 ms. For subjects with intraventricular conduction block (QRS interval > 120 ms), JTc interval may be used instead of QTc interval (if JTc is used, it must be ≤ 340 ms).
- Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg despite optimal medical treatment; a history of hypertensive crisis or hypertensive encephalopathy.
- Severe acute infection that is uncontrolled; current fever (> 38℃), purulent or chronic infection, or unhealed wounds.
- Patients with radiologically confirmed loculated peritoneal effusion; definitely diagnosed peritoneal infection.
- Active acute or chronic hepatitis B or C infection, with hepatitis B virus (HBV) DNA > 2000 IU/mL or 10⁴ copies/mL; hepatitis C virus (HCV) RNA > 10³ copies/mL; concurrent positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibody. Subjects who have received nucleoside analog antiviral therapy and achieved viral load below the above thresholds are eligible for enrollment. A known history of human immunodeficiency virus (HIV) infection or confirmed positive HIV test results.
- Evidence or history of obvious bleeding tendency within 3 months prior to enrollment (bleeding > 30 mL within 3 months, hematemesis, melena, hematochezia); hemoptysis (> 5 mL of fresh blood within 4 weeks); a history of hereditary or acquired bleeding disorders or coagulation dysfunction. Clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to enrollment (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer).
- A history of arterial or venous thrombotic disease within 6 weeks prior to enrollment.
- A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Receipt of major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or anticipated need for major surgery during the study treatment period.
- Failure to achieve adequate recovery from toxicity and/or complications of major surgery prior to the start of treatment.
- Pregnant or lactating women; or subjects who plan to conceive or give birth during the study period from screening visit to completion of safety follow-up visit (90 days after the last dose for male subjects).
- Receipt of radiotherapy within 4 weeks prior to the first dose of study drug.
- Radiotherapy-related toxicities in subjects must have fully resolved, without the need for corticosteroid therapy, and radiation pneumonitis must be definitely excluded. For palliative radiotherapy for non-central nervous system (CNS) diseases, a 2-week washout period is permitted.
- Uncontrolled neurological or psychiatric diseases/disorders with poor compliance, resulting in inability to cooperate or report treatment responses. Uncontrolled primary brain tumors or central nervous system metastases with obvious intracranial hypertension or neuropsychiatric symptoms.
- Other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wang Yingnan contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510555
Yingnan Wang, +86 15521145855, wangyn@sysucc.org.cn
About this study
Official title: Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy：A Phase Ib/II Clinical Study
This study is a prospective, multi-cohort Phase Ib/II clinical trial, consisting of two stages as follows:
- Phase Ib Dose-Escalation Stage To explore the dose-limiting toxicities (DLT) of intraperitoneally administered liposomal irinotecan in patients with malignant peritoneal effusion who have failed prior standard therapy, and to estimate the maximum tolerated dose (MTD) of the investigational agent.
- Phase II Expansion Stage To evaluate the efficacy and safety of liposomal irinotecan as monotherapy or in combination with recombinant modified human tumor necrosis factor or bevacizumab, in the treatment of malignant peritoneal effusion in patients who have failed prior standard therapy.
- Conditions
- Malignant Ascites
- Being tested
- liposomal irinotecan monotherapy, Liposomal Irinotecan + rmhTNF-NC, Liposomal Irinotecan + Bevacizumab
- Keywords
- Liposomal Irinotecan, Recombinant Mutant Human Tumor Necrosis Factor, Bevacizumab, Malignant Ascites, Intraperitoneal Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal irinotecan monotherapyDrug
A "3+3" dose-escalation design will be adopted. A total of 9-18 eligible subjects will receive liposomal irinotecan treatment, with three predefined dose levels as follows:
Dose Level 1: 20 mg, intraperitoneal injection (ip), administered on Day 1, Day 8, Day 15, and Day 21.
Dose Level 2: 30 mg, intraperitoneal injection (ip), administered on Day 1, Day 8, Day 15, and Day 21.
Dose Level 3: 40 mg, intraperitoneal injection (ip), administered on Day 1, Day 8, Day 15, and Day 21.
Each subject will receive only one treatment cycle. The dosage of liposomal irinotecan will be escalated gradually from the lowest dose level to the highest. Dose-limiting toxicities (DLT) will be monitored throughout the administration cycle. Each subject will receive only one dose level of liposomal irinotecan during the study period. All subjects will complete the relevant tests specified in the protocol during treatment to evaluate safety and preliminary efficacy. Subsequent treatment regimens will be selecte
liposomal irinotecan monotherapyDrug
Liposomal irinotecan (at RP2D, intraperitoneal injection [ip], administered on Day 1, Day 8, Day 15 and Day 21).
Liposomal Irinotecan + rmhTNF-NCDrug
Liposomal Irinotecan (at RP2D dose, ip, D1, D8, D15, D21) rmhTNF-NC (300 IU per administration, ip, D1, D8, D15)
Liposomal Irinotecan + BevacizumabDrug
Liposomal Irinotecan (at RP2D dose, ip, D1, D8, D15, D21) Bevacizumab (100 mg, ip, D1, D15)
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib Dose-Escalation Stage | Experimental | Not described Receives: Drug: liposomal irinotecan monotherapy |
| Phase II Expansion Stage-ARM A | Experimental | Not described Receives: Drug: liposomal irinotecan monotherapy |
| Phase II Expansion Stage-ARM B | Experimental | Not described Receives: Drug: Liposomal Irinotecan + rmhTNF-NC |
| Phase II Expansion Stage-ARM C | Experimental | Not described Receives: Drug: Liposomal Irinotecan + Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Defined as the highest dose at which less than 33% of subjects experience dose-limiting toxicity (DLT).
Measured: 4 weeks after administration
Objective Response Rate
The proportion of subjects achieving complete response and partial response per WHO criteria.
Measured: Up to 4 weeks after the first cycle
Secondary outcomes (4)
Duration of Response
The time interval from the first documentation of objective response in malignant ascites, to the first documentation of disease progression of ascites or death due to any cause, evaluated per the WHO criteria for malignant ascites.
Measured: from the first documentation of CR/PR to PD/death, up to 1 year
Disease control rate
The proportion of subjects achieving complete response, partial response, or stable disease in malignant ascites, evaluated per the WHO criteria.
Measured: 4 weeks after first treatment cycle
Safety and Tolerability
The severity of adverse events will be graded and assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0,
Measured: through study completion, an average of 1 year
Quality of Life
Assessment will be performed using the Chinese version of the Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI) to evaluate the impact of malignant ascites and treatment on patients' physical function, symptom burden, and daily living ability.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start28 Nov 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong sheng Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Pharmaceutical Group Limited
- Responsible party
- Sponsor-investigator, Dong sheng Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397819
- Sponsor's protocol ID
- SL-B2025-503-02
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy：A Phase Ib/II Clinical Study
- ClinicalTrials.gov ID
- NCT07397819
- Acronym / sponsor ID
- SL-B2025-503-02
- Conditions
- Malignant Ascites
- Keywords
- Liposomal Irinotecan, Recombinant Mutant Human Tumor Necrosis Factor, Bevacizumab, Malignant Ascites, Intraperitoneal Injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dong sheng ZhangUniversity, hospital or other
- Collaborators
- CSPC Pharmaceutical Group Limited
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 9 Feb 2026 (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 study is a prospective, multi-cohort Phase Ib/II clinical trial, consisting of two stages as follows:
- Phase Ib Dose-Escalation Stage To explore the dose-limiting toxicities (DLT) of intraperitoneally administered liposomal irinotecan in patients with malignant peritoneal effusion who have failed prior standard therapy, and to estimate the maximum tolerated dose (MTD) of the investigational agent.
- Phase II Expansion Stage To evaluate the efficacy and safety of liposomal irinotecan as monotherapy or in combination with recombinant modified human tumor necrosis factor or bevacizumab, in the treatment of malignant peritoneal effusion in patients who have failed prior standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase Ib Dose-Escalation Stage | Experimental | Drug: liposomal irinotecan monotherapy |
| Phase II Expansion Stage-ARM A | Experimental | Drug: liposomal irinotecan monotherapy |
| Phase II Expansion Stage-ARM B | Experimental | Drug: Liposomal Irinotecan + rmhTNF-NC |
| Phase II Expansion Stage-ARM C | Experimental | Drug: Liposomal Irinotecan + Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged ≥18 years old, gender unrestricted.
- Histologically or cytologically confirmed malignant peritoneal effusion derived from digestive system tumors (malignancy confirmed by ascites cytology, or peritoneal metastases diagnosed clinically based on imaging findings and symptoms).
- Moderate to large volume of peritoneal effusion, with failure of initial treatment or previous intraperitoneal therapy with conventional chemotherapeutic agents and/or biological response modifiers. Moderate volume of ascites is defined as: ①Ascites depth ≥3 cm confirmed by supine abdominal ultrasound; ② Presence of clinical symptoms (chest distress, dyspnea, abdominal distension and discomfort) judged by the investigator to be related to peritoneal effusion.
- ECOG performance status score 0-2.
- Expected survival time >3 months.
Key exclusion criteria (22 listed)
- History of hypersensitivity to tumor necrosis factor (TNF), its derivative drugs, bevacizumab or its analogs, irinotecan, or liposomal irinotecan.
- Diagnosis of malignant diseases other than gastrointestinal tumors within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ).
- Receipt of any other investigational drug treatment or participation in an interventional clinical trial within 7 days prior to the first dose; or receipt of anti-tumor therapy (including Chinese herbal medicines with anti-tumor indications) within 7 days prior to the first dose of the study drug.
- Pregnant or lactating women; women of childbearing potential who are unwilling to take contraceptive measures during the study period; or men who are unwilling to use effective contraceptive measures during treatment and for 1 year thereafter.
- Significant impairment of major organ function.
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 |
|---|---|---|
| liposomal irinotecan monotherapyA "3+3" dose-escalation design will be adopted. A total of 9-18 eligible subjects will receive liposomal irinotecan treatment, with three predefined dose levels as follows: Dose Level 1: 20 mg, intraperitoneal injection (ip), administered on Day 1, Day 8, Day 15, and Day 21. Dose Level 2: 30 mg, intraperitoneal injection (ip), administered on Day 1, Day 8, Day 15, and Day 21. Dose Level 3: 40 mg, intraperitoneal injection (ip), administered on Day 1, Day 8, Day 15, and Day 21. Each subject will receive only one treatment cycle. The dosage of liposomal irinotecan will be escalated gradually from the lowest dose level to the highest. Dose-limiting toxicities (DLT) will be monitored throughout the administration cycle. Each subject will receive only one dose level of liposomal irinotecan during the study period. All subjects will complete the relevant tests specified in the protocol during treatment to evaluate safety and preliminary efficacy. Subsequent treatment regimens will be selecte | Drug | Phase Ib Dose-Escalation Stage |
| liposomal irinotecan monotherapyLiposomal irinotecan (at RP2D, intraperitoneal injection [ip], administered on Day 1, Day 8, Day 15 and Day 21). | Drug | Phase II Expansion Stage-ARM A |
| Liposomal Irinotecan + rmhTNF-NCLiposomal Irinotecan (at RP2D dose, ip, D1, D8, D15, D21) rmhTNF-NC (300 IU per administration, ip, D1, D8, D15) | Drug | Phase II Expansion Stage-ARM B |
| Liposomal Irinotecan + BevacizumabLiposomal Irinotecan (at RP2D dose, ip, D1, D8, D15, D21) Bevacizumab (100 mg, ip, D1, D15) | Drug | Phase II Expansion Stage-ARM C |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 4 weeks after administration
Defined as the highest dose at which less than 33% of subjects experience dose-limiting toxicity (DLT).
Objective Response Rate
Time frame: Up to 4 weeks after the first cycle
The proportion of subjects achieving complete response and partial response per WHO criteria.
4 secondary outcomes
Duration of Response
Time frame: from the first documentation of CR/PR to PD/death, up to 1 year
Disease control rate
Time frame: 4 weeks after first treatment cycle
Safety and Tolerability
Time frame: through study completion, an average of 1 year
Quality of Life
Time frame: through study completion, an average of 1 year
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 9 Feb 2026.
- 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.
Wang Yingnan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing liposomal irinotecan monotherapy, Liposomal Irinotecan + rmhTNF-NC and Liposomal Irinotecan + Bevacizumab in people with Malignant Ascites, run by Dong sheng Zhang at 1 site 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 14 inclusion and 22 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 9 Feb 2026. 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 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 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?
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 Zhang Dongsheng (13719437860, zhangdsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 4 weeks after administration). The study lists 2 primary outcomes in all. 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 9 Feb 2026.