Ovarian Clear Cell CarcinomaNCT05600998
A Study of Camrelizumab in Combination With Anlotinib in Subjects Advanced Ovarian Clear Cell Carcinoma
A study testing Camrelizumab in people with Ovarian Clear Cell Carcinoma, run by Peking University Third Hospital.
Trial summary
This study is prospective ,open-label, single-center phase II clinical study. Target population is patients with advanced (stage III-IV) ovarian clear cell carcinoma. Study objective is to evaluate effectiveness response of Camrelizumab + anlotinib in subjects with advanced ovarian clear cell carcinoma Camrelizumab is… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ovarian Clear Cell Carcinoma
- What is being tested?
- Camrelizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2022to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 1. Age 18-75 years; 2. Pathohistological or cytology confirmed as ovarian transparent cell carcinoma, and FIGO stage in 2018 is stage III-IV; ≥ four courses of chemotherapy and failed to reach CR 3. ECOG score; 0-2 points; 4. Expected survival ≥ 3 months; 5. The investigator confirmed to have at least one measurable lesion (10 mm long diameter of CT scan of tumor lesions ≥10 mm, short diameter of CT scan of lymph node lesions ≥15 mm)) according to the RECIST 1.1 standard), or ascites 6. The main organs function normally, and the test results during screening must meet the following requirements:
- Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors to correct):
- Hemoglobin (Hb) ≥ 80 g/L; B. Number of neutrophils (ANC) ≥ 1.5 × 109/L; C. Platelet count (PLT) ≥ 80 ×109/L;
- Biochemical inspection must meet the following standards:
- Total bilirubin (TBIL) < 1.5 Upper limit of normal value (ULN); B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 ULL compared <with 5 ULN for patients with liver metastases; C. serum creatinine (Cr) ≤ 1.5 ULN or endogenous creatinine clearance > 60 ml/min (Cockcroft-Galt formula); D. Urine routine test results show urine protein (UPRO) < 2+ or 24-hour urine protein quantitative <1 g; 7. Women of gestational age must agree to adequate contraception for the entire duration of the study and within 6 months after the end of treatment.
- 8.Signed a written informed consent form with good expected adherence to the research protocol.
Who cannot join
- Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies acting on the T cell synergistic stimulation or checkpoint pathway);
- Previous exposure to other anti-angiogenic small molecule TKI drugs, such as apatinib, alotinib, sorafinil, regofinib, etc.;
- Patients with active brain metastases (for patients with stable symptoms after treatment of brain metastases, they can be selected if they remain in a stable state for at least 4 weeks);
- Immunosuppressive drugs have been used within 28 days before the first use of carirelizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones in physiological doses (i.e., prednisolone or other corticosteroids of equivalent pharmacophysiological doses not exceeding 10 mg / day);
- Received systematic systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory effect (including thymus peptide, interferon, interleukin, except for the control of pleural effusion topical use) within 2 weeks before the first administration;
- Suffering from serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval men ≥ 450 ms, women ≥ 470 ms); Grade III. to IV. cardiac insufficiency (see Annex 3 according to the NYHA grade of the New York Cardiology Society), or if the left ventricular ejection fraction (LVEF) < 50% on cardiac color ultrasound;
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- Complicated by severe infection within 4 weeks before the first medication (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > during screening / before the first administration 38.5°C； or major surgical treatment within 3 weeks prior to the first medication;
- The presence of active autoimmune diseases or immunodeficiency, or the history of the above, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, pituititis, vasculitis, nephritis, etc.) shall not be included. The following exceptions are those with a history of autoimmune hypothyroidism but receiving thyroid hormone replacement therapy. After treatment with an insulin dosing regimen, patients with type 1 diabetes whose blood glucose is controlled may participate in this study.
- Subjects undergo systematic treatment such as bronchodilators, asthma control is not satisfactory, can not be included (asthma in childhood has been completely resolved, adults do not need any intervention can be included).
- Human immunodeficiency virus (HIV) infection or known to have acquired immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the lower limit of detection of analytical methods) or co-infection with hepatitis B and C;
- The subject has received or plans to receive a transplant of a solid organ or blood system during the study (except for corneal transplantation);
- Are currently participating in interventional clinical research or has been treated with other experimental drugs or research devices within 4 weeks prior to the first dose; Adequate recovery from toxicity and/or complications caused by any intervention before the first dose (i.e., ≦ grade 1 or at baseline, excluding fatigue or hair loss);
- Have a clear history of allergies, may be potentially allergic or intolerant to the test drug and its similar biological agents;
- Those with a history of psychotropic drug abuse and who cannot be withdrawn or have mental disorders;
- People with a history of hereditary or acquired bleeding or coagulation dysfunction (it is up to the investigator to determine whether they can be selected)
- Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug therapy);
- Those who have had significant coughing up blood 2 months prior to entry into the study, or who have had a daily hemoptysis volume of half a teaspoon (2.5 ml) or more; or have had clinically significant bleeding symptoms or a clear tendency to bleed within 3 months prior to the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis; or arteriovenous thrombosis events that occurred within 6 months prior to the study, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT >1.5ULN), with bleeding tendencies or being undergoing thrombolytic or anticoagulant therapy;
- Urine routine suggests that urine protein ≥++, or confirm that the amount of urine protein ≥ 1.0g in 24 hours;
- Increases the risk associated with participating in a study or trial drug and, according to the investigator's judgment, can lead to other circumstances in which the patient is unsuitable for the study to be selected.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exploratory Clinical Study of Camrelizumab in Combination With Anlotinib in the Treatment of Patients With Advanced Ovarian Clear Cell Carcinoma
This study is prospective ,open-label, single-center phase II clinical study. Target population is patients with advanced (stage III-IV) ovarian clear cell carcinoma. Study objective is to evaluate effectiveness response of Camrelizumab + anlotinib in subjects with advanced ovarian clear cell carcinoma Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.
Read the detailed description
In this study, eligible subjects were given a combination of carrelizumab and alozantinib at the same time, repeated every 21 days, during treatment based on imaging evaluation of the patient if disease progression, toxicity intolerance, or other reasons specified by the regimen could be terminated.
- Conditions
- Ovarian Clear Cell Carcinoma
- Being tested
- Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called Anlotinib
Subjects will receive carilizumab every three weeks, with alozantinib 20 mg orally daily for 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+Anlotinib | Experimental | Subjects will receive carilizumab every three weeks, with alozantinib 20 mg orally daily for 9 weeks Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Evaluated according to RECIST1.1, refers to the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time. Specifically, the proportion of the total number of treated CR+PR cases to the overall number of measurable cases.
Measured: 12 weeks
Secondary outcomes (1)
Progression-free survival
Defined as the date on which the subject begins with the first treatment to the date on which the tumor progression is first recorded or dies for any reason, whichever appears first.
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start30 Oct 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Clear Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongyan Guo, Doctor, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600998
- Sponsor's protocol ID
- IIT-SHR1210
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2022
- Last updated
- 1 Nov 2022
- 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 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Camrelizumab in Combination With Anlotinib in the Treatment of Patients With Advanced Ovarian Clear Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05600998
- Acronym / sponsor ID
- IIT-SHR1210
- Conditions
- Ovarian Clear Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 1 Nov 2022 (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 prospective ,open-label, single-center phase II clinical study. Target population is patients with advanced (stage III-IV) ovarian clear cell carcinoma. Study objective is to evaluate effectiveness response of Camrelizumab + anlotinib in subjects with advanced ovarian clear cell carcinoma Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.
Detailed description
In this study, eligible subjects were given a combination of carrelizumab and alozantinib at the same time, repeated every 21 days, during treatment based on imaging evaluation of the patient if disease progression, toxicity intolerance, or other reasons specified by the regimen could be terminated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+Anlotinib | Experimental | Drug: CamrelizumabSubjects will receive carilizumab every three weeks, with alozantinib 20 mg orally daily for 9 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Age 18-75 years; 2. Pathohistological or cytology confirmed as ovarian transparent cell carcinoma, and FIGO stage in 2018 is stage III-IV; ≥ four courses of chemotherapy and failed to reach CR 3. ECOG score; 0-2 points; 4. Expected survival ≥ 3 months; 5. The investigator confirmed to have at least one measurable lesion (10 mm long diameter of CT scan of tumor lesions ≥10 mm, short diameter of CT scan of lymph node lesions ≥15 mm)) according to the RECIST 1.1 standard), or ascites 6. The main organs function normally, and the test results during screening must meet the following requirements:
- Blood routine examination criteria should be met (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors to correct):
- Biochemical inspection must meet the following standards:
- Total bilirubin (TBIL) < 1.5 Upper limit of normal value (ULN); B. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 ULL compared <with 5 ULN for patients with liver metastases; C. serum creatinine (Cr) ≤ 1.5 ULN or endogenous creatinine clearance > 60 ml/min (Cockcroft-Galt formula); D. Urine routine test results show urine protein (UPRO) < 2+ or 24-hour urine protein quantitative <1 g; 7. Women of gestational age must agree to adequate contraception for the entire duration of the study and within 6 months after the end of treatment.
- 8.Signed a written informed consent form with good expected adherence to the research protocol.
Key exclusion criteria (20 listed)
- Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies acting on the T cell synergistic stimulation or checkpoint pathway);
- Previous exposure to other anti-angiogenic small molecule TKI drugs, such as apatinib, alotinib, sorafinil, regofinib, etc.;
- Patients with active brain metastases (for patients with stable symptoms after treatment of brain metastases, they can be selected if they remain in a stable state for at least 4 weeks);
- Immunosuppressive drugs have been used within 28 days before the first use of carirelizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones in physiological doses (i.e., prednisolone or other corticosteroids of equivalent pharmacophysiological doses not exceeding 10 mg / day);
- Received systematic systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory effect (including thymus peptide, interferon, interleukin, except for the control of pleural effusion topical use) within 2 weeks before the first administration;
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 |
|---|---|---|
| CamrelizumabAlso: AnlotinibSubjects will receive carilizumab every three weeks, with alozantinib 20 mg orally daily for 9 weeks | Drug | Camrelizumab+Anlotinib |
Primary outcome
Objective Response Rate
Time frame: 12 weeks
Evaluated according to RECIST1.1, refers to the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time. Specifically, the proportion of the total number of treated CR+PR cases to the overall number of measurable cases.
1 secondary outcome
Progression-free survival
Time frame: 12weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- 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. This study is not recruiting at the moment.
Hongyan Guo, Doctor principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Camrelizumab in people with Ovarian Clear Cell Carcinoma, run by Peking University Third Hospital.
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 6 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongyan Guo, Doctor (+86 010-82267510, bysyghy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 12 weeks). 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 1 Nov 2022.