Ovarian CancerPhase 1/2NCT06884345
METR-NK Cells in Combination With Anti-angiogenic Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer
A Phase 1/2 study testing METR-NK cells combined with Solvatinib in people with Ovarian Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial summary
To further evaluate and observe the efficacy and safety of solantinib combined with METR-NK neoadjuvant therapy for advanced epithelial ovarian cancer in patients with advanced epithelial ovarian cancer by using solantinib combined with METR-NK neoadjuvant therapy Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- METR-NK cells combined with Solvatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2025to 31 Dec 2028
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old (≥18, ≤70);
- Open surgery, laparoscopic surgery or coarse needle puncture biopsy and pathology confirmed late in the center of the local laboratory (FIGO IIIC/IV) high grade serous ovarian cancer, high grade endometrial carcinoma, and/or primary peritoneal carcinoma fallopian tube carcinoma epithelial ovarian cancer; Organization/blood samples confirmed HRD positive;
- ECOG score: 0-1;
- before, during, and after treatment of blood and tissue samples can get, and the participants agreed to at the center of the blood and tissue samples to laboratory for the expansion of the trial research purposes.
- At least one measurable lesions, CT/MRI according to RECIST 1.1 standard; • • Expectations alive at least 3 months;
- By professional gynecological oncologist judgment cannot achieve R0 reduced tumor or cannot tolerate surgery patients, cannot achieve the judgment standard of R0 reduced tumor including but not limited to:
Show all 13Show fewer
- Fagotti cavity mirror scoring eight points or more; 2) when the laparoscopic evaluation methods is difficult to implement, can be used on abdominal CT score 3 points or more;
- Can't tolerate surgery judgment standard may be considered: age: the age of 70 or higher; Body mass index (BMI) : BMI 40.0 or higher; A variety of chronic diseases; Malnutrition or hypoalbuminemia; To a large number of ascites; A new diagnosis of venous thromboembolism (greater than 12 weeks of survival);
- Main organs function within 7 days before the treatment, meet the following criteria: hematologic studies: 90 g/L or higher hemoglobin, white blood cells or 3 x 109 / L, neutrophil count (ANC) absolutely acuity 1.5 x 109 / L, platelets or 90 x 109 / L; Kidney: serum creatinine < 1.5 mg/dl, glomerular filtration rate (GFR) or greater 50 ml/min (based on the screening of Fairview Laboratories formula); Liver: AST, ALT, and alkaline phosphatase (agency 3 times normal limit, total bilirubin < 1.5 times that of the upper limit of normal; Lung function: resting state oxygen saturation under 90% or more; Heart function: by echocardiography, MUGA or cardiac magnetic resonance imaging (MRI) of 40% or more LVEF; There was no electrocardiographic evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, or acute ischemia or active conduction system abnormalities;
- Two months without obstruction history;
- Childbearing age patients effective birth control measures should be taken;
- Subjects were willing to join in this study, and sign the informed consent (ICF);
- Expected, adherence to the good curative effect and adverse reaction will be effected according to the plan calls for follow-up.
Who cannot join
- Patients who have received drugs or other cell immunotherapy in other clinical trials within 28 days before the screening period;
- Patients who have had other malignant tumors in the past 5 years;
- Acute illnesses are ongoing, or severe illnesses have occurred in the past 2 years, such as patients with active infections or fever, cardiovascular diseases (Grade III or IV heart failure), mental health issues (such as alcoholism, drug abuse);
- History of immunodeficiency, including HIV-positive status or other acquired, congenital immunodeficiency diseases;
- Organ transplant or organ failure patients, patients receiving immunosuppressive therapy after organ transplantation, or patients taking immunosuppressive drugs long-term;
- Thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism within 6 months;
Show all 10Show fewer
- Known allergy to any component of the final product of METR-NK preparation, including human serum albumin;
- Breastfeeding during the screening period or female subjects with positive serum or urine pregnancy tests;
- Patients with mental illnesses, including epilepsy, dementia, severe depression, bipolar disorder, etc.;
- Other conditions deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of METR-NK Cells Combined With Solantinib Neoadjuvant Therapy in HRD+ Advanced Epithelial Ovarian Cancer: a Single-arm, Single-center, Exploratory Clinical Study
To further evaluate and observe the efficacy and safety of solantinib combined with METR-NK neoadjuvant therapy for advanced epithelial ovarian cancer in patients with advanced epithelial ovarian cancer by using solantinib combined with METR-NK neoadjuvant therapy
Read the detailed description
Sorafenib 250mg po qd, 3 weeks as a course, a total of 3 courses. Dilute METR - 200 mL of NK cells in 37 ℃ 1500 mL of 0.9% sodium chloride physiological saline, intraperitoneal infusion, flow rate > 150 drops/min, each METR - venous back to the throughput of NK cells is lower than 2 x 107 cells/kg, abdominal cavity to throughput of no less than 4 x 107 cells/kg, Three consecutive reinfusion days were taken as a course, and four consecutive reinfusion courses were given, with an interval of 14 days between each course. The position was changed every 15 min after the end of each infusion to ensure that the cells were evenly distributed to the tumor surface to achieve the therapeutic effect.
- Conditions
- Ovarian Cancer
- Being tested
- METR-NK cells combined with Solvatinib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METR-NK cells combined with SolvatinibDrug
Sorafenib 250mg po qd, 3 weeks as a course, a total of 3 courses, the drug was stopped 3 weeks before cytoreduction of intermediate tumor.
Dilute METR - 200 mL of NK cells in 37 ℃ 1500 mL of 0.9% sodium chloride physiological saline, intraperitoneal infusion, flow rate > 150 drops/min, each METR - venous back to the throughput of NK cells is lower than 2 x 107 cells/kg, abdominal cavity to throughput of no less than 4 x 107 cells/kg, Three days of continuous infusion was taken as a course of treatment, and four courses of continuous infusion (the first course of infusion did not use METR-NK cells) were given, with an interval of 14 days for each course. The position was switched every 15 min after the completion of each infusion to ensure uniform distribution of cells to the tumor surface.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Drug: METR-NK cells combined with Solvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
the percentage of patients received R0 resection after METR-NK cells as neoadjuvant therapy for advanced epithelial ovarian cancer
Measured: 3-month
Secondary outcomes (6)
Overall Response Rate (ORR) After Neoadjuvant treatment
Measured: 3-month
Pathological complete remission rate
Measured: 3-month
Disease control rate
Measured: 3-month
Progression free survival
Measured: 2-years
Survival rate
Measured: 3-years
Adverse event
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start13 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bai-Rong Xia, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884345
- Sponsor's protocol ID
- 2025 NO.01
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of METR-NK Cells Combined With Solantinib Neoadjuvant Therapy in HRD+ Advanced Epithelial Ovarian Cancer: a Single-arm, Single-center, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06884345
- Acronym / sponsor ID
- 2025 NO.01
- Conditions
- Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Mar 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.
To further evaluate and observe the efficacy and safety of solantinib combined with METR-NK neoadjuvant therapy for advanced epithelial ovarian cancer in patients with advanced epithelial ovarian cancer by using solantinib combined with METR-NK neoadjuvant therapy
Detailed description
Sorafenib 250mg po qd, 3 weeks as a course, a total of 3 courses. Dilute METR - 200 mL of NK cells in 37 ℃ 1500 mL of 0.9% sodium chloride physiological saline, intraperitoneal infusion, flow rate > 150 drops/min, each METR - venous back to the throughput of NK cells is lower than 2 x 107 cells/kg, abdominal cavity to throughput of no less than 4 x 107 cells/kg, Three consecutive reinfusion days were taken as a course, and four consecutive reinfusion courses were given, with an interval of 14 days between each course. The position was changed every 15 min after the end of each infusion to ensure that the cells were evenly distributed to the tumor surface to achieve the therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: METR-NK cells combined with Solvatinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-70 years old (≥18, ≤70);
- Open surgery, laparoscopic surgery or coarse needle puncture biopsy and pathology confirmed late in the center of the local laboratory (FIGO IIIC/IV) high grade serous ovarian cancer, high grade endometrial carcinoma, and/or primary peritoneal carcinoma fallopian tube carcinoma epithelial ovarian cancer; Organization/blood samples confirmed HRD positive;
- ECOG score: 0-1;
- before, during, and after treatment of blood and tissue samples can get, and the participants agreed to at the center of the blood and tissue samples to laboratory for the expansion of the trial research purposes.
- At least one measurable lesions, CT/MRI according to RECIST 1.1 standard; • • Expectations alive at least 3 months;
Key exclusion criteria (10 listed)
- Patients who have received drugs or other cell immunotherapy in other clinical trials within 28 days before the screening period;
- Patients who have had other malignant tumors in the past 5 years;
- Acute illnesses are ongoing, or severe illnesses have occurred in the past 2 years, such as patients with active infections or fever, cardiovascular diseases (Grade III or IV heart failure), mental health issues (such as alcoholism, drug abuse);
- History of immunodeficiency, including HIV-positive status or other acquired, congenital immunodeficiency diseases;
- Organ transplant or organ failure patients, patients receiving immunosuppressive therapy after organ transplantation, or patients taking immunosuppressive drugs long-term;
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 |
|---|---|---|
| METR-NK cells combined with SolvatinibSorafenib 250mg po qd, 3 weeks as a course, a total of 3 courses, the drug was stopped 3 weeks before cytoreduction of intermediate tumor. Dilute METR - 200 mL of NK cells in 37 ℃ 1500 mL of 0.9% sodium chloride physiological saline, intraperitoneal infusion, flow rate > 150 drops/min, each METR - venous back to the throughput of NK cells is lower than 2 x 107 cells/kg, abdominal cavity to throughput of no less than 4 x 107 cells/kg, Three days of continuous infusion was taken as a course of treatment, and four courses of continuous infusion (the first course of infusion did not use METR-NK cells) were given, with an interval of 14 days for each course. The position was switched every 15 min after the completion of each infusion to ensure uniform distribution of cells to the tumor surface. | Drug | experimental group |
Primary outcome
R0 resection rate
Time frame: 3-month
the percentage of patients received R0 resection after METR-NK cells as neoadjuvant therapy for advanced epithelial ovarian cancer
6 secondary outcomes
Overall Response Rate (ORR) After Neoadjuvant treatment
Time frame: 3-month
Pathological complete remission rate
Time frame: 3-month
Disease control rate
Time frame: 3-month
Progression free survival
Time frame: 2-years
Survival rate
Time frame: 3-years
Adverse event
Time frame: 3-month
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 Mar 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 METR-NK cells combined with Solvatinib in people with Ovarian Cancer, run by Anhui Provincial Cancer Hospital 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 13 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 3-month). 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 Mar 2025.