Cancer of Stomach, AdenocarcinomaPhase 1/2IPIZANCT06759064
Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids for Gastric Cancer Malignant Ascites
A Phase 1/2 study testing zoledronic acid plus Sintilimab intraperitoneal injection in people with Cancer of Stomach, Adenocarcinoma and Ascites, Malignant, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study is to evaluate the safety and efficacy of intraperitoneal injection of immune checkpoint inhibitor combined with zoledronic acid for the treatment of malignant ascites in gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer of Stomach, Adenocarcinoma, Ascites, Malignant
- What is being tested?
- zoledronic acid plus Sintilimab intraperitoneal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2024to 1 Sep 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric adenocarcinoma diagnosed pathologically;
- Malignant ascites confirmed by ascites cytology;
- Presence of ascites confirmed by CT with ascites graded as 2nd and 3rd degree (EASL guidelines and ICA consensus);
- Those aged 18-75 years;
- Patients who had not undergone local administration of drugs in the abdominal cavity and systemic immunotherapy within the previous 4 weeks;
- Vital signs are stable, Karnofsky score (≥70), and expected survival time is >3 months;
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- Normal bone marrow haematopoietic function, blood routine: HGB ≥90g/L, WBC ≥2.5×10^9/L (NEU ≥1.5×10^9/L), PLT ≥90×10^9/L;
- Normal coagulation function without bleeding tendency (International normalised ratio of prothrombinogen INR<1.5);
- Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN); AST and ALT ≤2 times the upper limit of normal (ULN) (or ≤5 times the upper limit of normal (ULN) if the abnormalities are mainly due to tumour infiltration);
- Renal function: Cr ≤1.5 times the upper limit of normal (ULN) or creatinine clearance ≥60mL/min.
Who cannot join
- Non-malignant ascites (e.g., portal hypertension ascites or infected ascites);
- Presence of contraindications to immunotherapy (including long-term hormone use, history of radiation pneumonitis, radiation hepatitis, radiation enteritis, etc.);
- Combination of other serious cardiopulmonary diseases that affect the treatment, etc;
- Patients with extensive abdominal adhesions; encapsulated peritoneal fluid; history of intestinal obstruction; and malignant patients with extensive distant metastases in the terminal stage;
- Women who are breastfeeding, pregnant, or preparing for pregnancy;
- Patients with plasma albumin (ALB) <30 g/L and severe hypoproteinemia;
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- Patients with known hypersensitivity to components of the test drug or its analogues;
- Patients with other severe, acute or chronic diseases that may interfere with the interpretation of the study results and who, in the judgement of the investigator, are unsuitable for participation in the clinical trial;
- Patients with cognitive dysfunction, or poor treatment compliance as judged by the investigator;
- Participants in other clinical trials within 4 weeks;
- Combination of other malignancies;
- Those who, in the opinion of the investigator, are not suitable for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Song Li, MD, PhD, +8618560087836, songli@sdu.edu.cn
Lian Liu
About this study
Official title: Efficacy and Safety of Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids in Gastric Cancer Malignant Ascites: a Phase I/II Clinical Study (IPIZA)
This study is to evaluate the safety and efficacy of intraperitoneal injection of immune checkpoint inhibitor combined with zoledronic acid for the treatment of malignant ascites in gastric cancer.
This study is a phase Ib/II clinical study to evaluate the safety and efficacy of intraperitoneal injection of immune checkpoint inhibitors in combination with zoledronic acid in the treatment of malignant ascites in gastric cancer, which consists of two phases, firstly, the phase Ib safety study, which adopts the '3+3' drug-escalation experimental design, and after determining the safe and tolerable dose, it will proceed to the second part of the phase II efficacy study. The Phase II study was designed by Simon's two-stage approach to evaluate the efficacy of immune checkpoint inhibitors in combination with zoledronic acid in the treatment of malignant ascites in gastric cancer.
- Being tested
- zoledronic acid plus Sintilimab intraperitoneal injection
- Keywords
- gastric cancer, malignant ascites, Immune checkpoint inhibitors, zoledronic acid, intraperitoneal injection
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acid plus Sintilimab intraperitoneal injectionDrug
At D-5~D-1, drain the ascites by placing a tube in the abdominal cavity first, try to drain the ascites as much as possible according to the clinical routine, and record the amount of drainage.D1, D8, D15, D22 start the first immunocheckpoint inhibitor combined with zoledronic acid treatment, try to drain the ascites first, calculate the amount of drugs according to the patient's body weight, and then dissolve the corresponding dosage of immunocheckpoint inhibitor and zoledronic acid in 100 ml of saline and inject them into the abdominal cavity respectively, and then inject another 100 ml of saline according to the patient's tolerance. The corresponding dose of immune checkpoint inhibitor and zoledronic acid was dissolved in 100 ml of saline and injected into the abdominal cavity.
| Study group | Role | What they receive |
|---|---|---|
| zoledronic acid plus Sintilimab intraperitoneal injection therapy arm | Experimental | patients will receive zoledronic acid 0.5-1mg plus Sintilimab 1.0mg/kg intraperitoneal injection Receives: Drug: zoledronic acid plus Sintilimab intraperitoneal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) or maximal tolerance dose (MTD) in the Phase Ib stage
Side effects of drug or treatment that are serious enough (e. g. ≥Grade 3 non-hematologic toxicity according to CTCAE 5.0 in ≥1/3) to prevent an increase in dose or level of that treatment. The MTD is defined as the previous dose level.
Measured: 28 days after the last treatment
Objective response rate
Complete remission (CR): complete resolution of ascites and maintained for more than 4 weeks; complete disappearance of all target lesions; Partial remission (PR): the amount of CT-measured ascites decreased by more than 50% compared to pretreatment and the amount of ascites withdrawn again was less than 1/2 of the previous withdrawal and was maintained for more than 4 weeks; the sum of the diameters of all measurable target lesions was ≥30% below baseline; Objective Response Rate（ORR） = CR + PR
Measured: 4 weeks after last treatment
Secondary outcomes (4)
Rates of Adverse events according to CTCAE 5.0 in overall subjects
Adverse events were graded and recorded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. A general physical examination, measurement of vital signs, laboratory safety evaluation, and documentation of relevant adverse events were performed at each visit during the treatment period.
Measured: 3 months after the last treatment
Time for ascites control
If PD was judged and ascites was not re-punctured and drained, the time of this follow-up visit was used as the time of ascites control; if the patient had undergone puncture and drainage prior to the follow-up visit due to intolerance of ascites symptoms, the time of re-puncture was used as the time of ascites control.
Measured: 1 year
Immune cell changes
Immune cell changes in ascites
Measured: 4 weeks
Quality of Life Assessment
A quality of life score (QOL) for oncology patients was used. The quality of life score (QOL) of oncology patients contains 12 dimensions, including appetite, spirit, sleep, fatigue, pain, family understanding and cooperation, colleagues' understanding and cooperation (including leadership), own knowledge of cancer, attitude towards treatment, daily life, side effects of treatment, and facial expression, with the highest score of 5 and the lowest score of 1 for each dimension. Quality of life grading: Quality of life is scored out of 60, with 51-60 for good, 41-50 for better, 31-40 for average, 21-30 for poor, and <20 for very poor quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start12 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Stomach, AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lian Liu, MD, PHD, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759064
- Sponsor's protocol ID
- IPIZA
- Acronym
- IPIZA
- Status last verified
- Nov 2025
- First submitted
- 10 Dec 2024
- Last updated
- 19 Nov 2025
- Results posted
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids in Gastric Cancer Malignant Ascites: a Phase I/II Clinical Study (IPIZA)
- ClinicalTrials.gov ID
- NCT06759064
- Acronym / sponsor ID
- IPIZA / IPIZA
- Keywords
- gastric cancer, malignant ascites, Immune checkpoint inhibitors, zoledronic acid, intraperitoneal injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Jan 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.
This study is to evaluate the safety and efficacy of intraperitoneal injection of immune checkpoint inhibitor combined with zoledronic acid for the treatment of malignant ascites in gastric cancer.
This study is a phase Ib/II clinical study to evaluate the safety and efficacy of intraperitoneal injection of immune checkpoint inhibitors in combination with zoledronic acid in the treatment of malignant ascites in gastric cancer, which consists of two phases, firstly, the phase Ib safety study, which adopts the '3+3' drug-escalation experimental design, and after determining the safe and tolerable dose, it will proceed to the second part of the phase II efficacy study. The Phase II study was designed by Simon's two-stage approach to evaluate the efficacy of immune checkpoint inhibitors in combination with zoledronic acid in the treatment of malignant ascites in gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zoledronic acid plus Sintilimab intraperitoneal injection therapy arm | Experimental | Drug: zoledronic acid plus Sintilimab intraperitoneal injectionpatients will receive zoledronic acid 0.5-1mg plus Sintilimab 1.0mg/kg intraperitoneal injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Gastric adenocarcinoma diagnosed pathologically;
- Malignant ascites confirmed by ascites cytology;
- Presence of ascites confirmed by CT with ascites graded as 2nd and 3rd degree (EASL guidelines and ICA consensus);
- Those aged 18-75 years;
- Patients who had not undergone local administration of drugs in the abdominal cavity and systemic immunotherapy within the previous 4 weeks;
Key exclusion criteria (12 listed)
- Non-malignant ascites (e.g., portal hypertension ascites or infected ascites);
- Presence of contraindications to immunotherapy (including long-term hormone use, history of radiation pneumonitis, radiation hepatitis, radiation enteritis, etc.);
- Combination of other serious cardiopulmonary diseases that affect the treatment, etc;
- Patients with extensive abdominal adhesions; encapsulated peritoneal fluid; history of intestinal obstruction; and malignant patients with extensive distant metastases in the terminal stage;
- Women who are breastfeeding, pregnant, or preparing for pregnancy;
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 |
|---|---|---|
| zoledronic acid plus Sintilimab intraperitoneal injectionAt D-5~D-1, drain the ascites by placing a tube in the abdominal cavity first, try to drain the ascites as much as possible according to the clinical routine, and record the amount of drainage.D1, D8, D15, D22 start the first immunocheckpoint inhibitor combined with zoledronic acid treatment, try to drain the ascites first, calculate the amount of drugs according to the patient's body weight, and then dissolve the corresponding dosage of immunocheckpoint inhibitor and zoledronic acid in 100 ml of saline and inject them into the abdominal cavity respectively, and then inject another 100 ml of saline according to the patient's tolerance. The corresponding dose of immune checkpoint inhibitor and zoledronic acid was dissolved in 100 ml of saline and injected into the abdominal cavity. | Drug | zoledronic acid plus Sintilimab intraperitoneal injection therapy arm |
Primary outcome
Dose-limiting toxicity (DLT) or maximal tolerance dose (MTD) in the Phase Ib stage
Time frame: 28 days after the last treatment
Side effects of drug or treatment that are serious enough (e. g. ≥Grade 3 non-hematologic toxicity according to CTCAE 5.0 in ≥1/3) to prevent an increase in dose or level of that treatment. The MTD is defined as the previous dose level.
Objective response rate
Time frame: 4 weeks after last treatment
Complete remission (CR): complete resolution of ascites and maintained for more than 4 weeks; complete disappearance of all target lesions; Partial remission (PR): the amount of CT-measured ascites decreased by more than 50% compared to pretreatment and the amount of ascites withdrawn again was less than 1/2 of the previous withdrawal and was maintained for more than 4 weeks; the sum of the diameters of all measurable target lesions was ≥30% below baseline; Objective Response Rate（ORR） = CR + PR
4 secondary outcomes
Rates of Adverse events according to CTCAE 5.0 in overall subjects
Time frame: 3 months after the last treatment
Time for ascites control
Time frame: 1 year
Immune cell changes
Time frame: 4 weeks
Quality of Life Assessment
Time frame: 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 19 Nov 2025.
- 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.
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 zoledronic acid plus Sintilimab intraperitoneal injection in people with Cancer of Stomach, Adenocarcinoma and Ascites, Malignant, run by Qilu Hospital of Shandong University 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 10 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) or maximal tolerance dose (MTD) in the Phase Ib stage (time frame: 28 days after the last treatment). 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 19 Nov 2025.