An observational study in Breast Cancer Metastatic, Hydrothorax and Ascites, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational
Among 43 studies in Ascites with a site in China — 14 open to participants now, 16 under way, 1 of them phase 3. Ascites · China.
Among the 43 studies in Ascites with a site in China, this one is one of 7 that started in 2024, is one of 6 observational ones, reaches primary completion later than 9 of the 15 other live ones, and was the 34th registered.
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
Browse Ascites studies →14 of the 43 studies in Ascites with a site in China are open now. Recruiting first, the newest first:
Zhejiang Cancer Hospital · Sites in China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Dong sheng Zhang · Sites in China
Jiangsu Simcere Pharmaceutical Co., Ltd. · Sites in China
C. R. Bard · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 41 Ascites studies recruiting now, 21 (51%) set no upper age limit and 13 (32%) stop at 75 or younger; 1 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 19 · Phase 3 8
First in 2009; this study’s year is marked. 7 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 90 is close to the median of 100 across 54 observational studies indexed under Ascites.
Median enrollment 48 across the 37 interventional studies, 285 across the 6 observational. Of the 17 that completed or were terminated, 1 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 43 have an industry lead sponsor. The 10 most frequent:
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Second Affiliated Hospital, School of Medicine, Zhejiang University has 1 study filed under Ascites — fewer than ten, so there is no comparison to draw.
3 of the studies in Ascites with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06433869Sun Yat-sen UniversityThe Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites | 2026-12-31 |
| NCT07007988Jiangsu Simcere Pharmaceutical Co., Ltd.A Phase I Study of SIM0388 in Participants With Malignant Ascites. | 2027-06 |
| NCT03020979The First Affiliated Hospital of Bengbu Medical UniversityA Clinical Trial With Apatinib for Subjects With Refractory Malignant Ascites | 2027-09 |
Among the 43 studies in Ascites with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Malignant hydrothorax and ascitic fluid in advanced breast cancer often arise from metastasis to the lungs, pleura, or liver. Patients with this condition experience rapid disease progression and multidrug resistance, facing limited treatment options. Clinical guidelines offer various therapies based on molecular subtypes; however, their effectiveness can be hindered by prior treatments, patient health, and tumor evolution. Current evaluations of treatment efficacy typically take two cycles, delaying the recognition of ineffective therapies and resulting in unnecessary side effects and costs. Organoid models present a promising solution, accurately replicating tumor structure and cellular diversity compared to traditional methods. These patient-derived models facilitate improved drug sensitivity testing, leading to more personalized treatment plans. In this study, 90 patients diagnosed with metastatic breast cancer accompanied by hydrothorax and ascitic fluid will be recruited. Patient-derived organoids will be used to assess the sensitivity of chemotherapy regimens, including Doxorubicin, Carboplatin, Cyclophosphamide, and Paclitaxel, along with targeted therapies such as Herceptin and Pertuzumab.
90 metastatic breast cancer patients with hydrothorax and ascitic fluid will be recruited. Baseline data, including medical history, ultrasound, and MRI records, will be collected both before and after two cycles of chemotherapy. Tumor samples from hydrothorax and ascitic fluid will be obtained and cultured to generate patient-derived organoids (PDOs). These PDOs will then be exposed to standard chemotherapeutic drugs used in breast cancer treatment. Organoid growth will be monitored post-treatment, and dose-response curves will be generated to assess drug sensitivity. To evaluate clinical outcomes, the RECIST criteria will be applied to measure tumor response in patients. Correlation analysis will be performed to determine the consistency between the treatment responses observed in the PDO models and the actual clinical outcomes of the patients.
metastatic breast cancer patients with hydrothorax and ascite fluid
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1.Patients not suitable for chemotherapy and target therapy
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before initiating therapy, patients diagnosed with metastatic breast cancer patients with hydrothorax and ascite fluid. The hydrothorax and ascite fluid is utilized to establish organoids and conduct drug testing.
Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes. The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes.
Time frame: 2024.10-2026.10
The sensitivity and specificity would be checked between drug sensitivity of organoid models in predicting the efficacy of treatment.
Time frame: 2024.10-2026.10
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Oct 2026, 23 months after the start.
Of 28 observational studies under Ascites, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 20. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →