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New treatment option for Cancer of Stomach, Adenocarcinoma
Official title Intraperitoneal Immune Checkpoint Inhibitors and Zoledronic Acids for Gastric Cancer Malignant Ascites
ClinicalTrials.gov ID: NCT06759064
What this study is testing
What is zoledronic acid plus Sintilimab intraperitoneal injection?
zoledronic acid plus Sintilimab intraperitoneal injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for cancer of stomach, adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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;
You likely can't join if
- 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...
- 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...
- Women who are breastfeeding, pregnant, or preparing for pregnancy;
- Patients with plasma albumin (ALB) \<30 g/L and severe hypoproteinemia;
See the full eligibility criteria
- 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;
- 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...
- Renal function: Cr ≤1.5 times the upper limit of normal (ULN) or creatinine clearance ≥60mL/min.
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.