Immune Checkpoint InhibitionNCT04507750
Camrelizumab Combined With Apatinib in the Treatment of Epithelial Ovarian Cancer
A study testing Camrelizumab in people with Immune Checkpoint Inhibition, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The aim of this study is to explore the effectiveness and safety of camrelizumab combined with apatinib mesylate in the treatment of relapsed platinum-resistant epithelial ovarian cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Immune Checkpoint Inhibition
- What is being tested?
- Camrelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2020to 30 Aug 2022
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age: 18 to 80 years old;
- 2. Histologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer;
- 3. Have received at least two lines of systemic chemotherapy;
- 4. Platinum resistance (disease progression occurs within 6 months after the last platinum-containing chemotherapy Development) or platinum refractory (disease progression during platinum-containing chemotherapy), ovarian cancer,Fallopian tube cancer, primary peritoneal cancer;
- 5. There are measurable lesions (according to RECIST 1.1 standard tumor lesion CT scan long diameter≥10mm, CT scan of lymph node lesions (short diameter≥ 10mm);
- 6. ECOG score: 0-1 points;
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- 7. Estimated survival period ≥ 3 months;
- 8. The main organs function well, and the inspection indicators meet the following requirements:Routine blood examination: hemoglobin ≥90 g/L (no blood transfusion within 14 days); neutrophil count ≥1.5×109/L; platelet count ≥80×109/L; biochemical examination: total bilirubin ≤1.5×ULN ( Upper limit of normal); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT or AST ≤ 5×ULN; endogenous creatinine clearance ≥ 50 ml/min (Cockcroft -Gault formula);
- 9. The main organs are functioning normally, no blood transfusion or blood products within 14 days;
- 10. Subjects of childbearing age must agree to take effective contraceptive measures during the trial;Age women's serum or urine pregnancy test must be negative; non-lactating patients;
- 11. Subjects voluntarily join the study and sign an informed consent form, with good compliance and matchingClose follow-up.
Who cannot join
- 1. The subject has any active autoimmune disease or a history of autoimmune disease;
- 2. Severe allergic reaction to other monoclonal antibodies;
- 3. Suffer from other malignant tumors at the same time, except for malignant tumors that have been cured or have stable disease;
- 4. The subject has previously received anti-PD-1, anti-PD-L1, anti-CD137 or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies (including ipilimumab or any other specific targeting T cell Co-stimulation or checkpoint pathway antibodies or drugs) treatment;
- 5. Pregnant or breastfeeding women;
- 6. Patients who have used anti-angiogenesis therapy in the past, including bevacizumab, apatinib, or anlotinib;
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- 7. Participated in other drug clinical trials within three months;
- 8. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, ulcerative colitis and intestinal obstruction, etc.);
- 9. Any bleeding event with a severity level of CTCAE4.0 or higher in the 4 weeks before screening;
- 10. Patients with known central nervous system metastasis or a history of central nervous system metastasis before screening;
- 11. Patients with hypertension who cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg); people with a history of unstable angina; a new diagnosis of angina within 3 months before screening Patients or myocardial infarction events occurred within 6 months before screening; Arrhythmia (including QTcF) requires long-term use of antiarrhythmic drugs and New York Heart Association grade ≥ Grade II cardiac insufficiency;
- 12. Long-term unhealed wounds or fractures with incomplete healing;
- 13. Have a history of organ transplantation;
- 14. Imaging shows that the tumor has invaded important blood vessels or the researcher has judged that the patient's tumor is highly likely to invade important blood vessels and cause fatal bleeding during treatment;
- 15. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), those with bleeding tendency (14 days before randomization must meet: INR is normal without using anticoagulants Within the range of values); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; on the premise of prothrombin time international normalized ratio (INR) ≤ 1.5, use for preventive purposes is permitted Low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (do not exceed 100 mg per day);
- 16. Arterial/venous thrombosis events occurred in the year before screening, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (venous thrombosis caused by intravenous catheterization due to pre-chemotherapy, except those who have been cured by the investigator ) And pulmonary embolism;
- 17. People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
- 18. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
- 19. Live vaccines may be vaccinated during the study period less than 4 weeks before the study medication;
- 20. Other researchers believe that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250014
Jing Liang, doctor, +8618663761275, liangjing0531@163.com
About this study
Official title: A Single-arm, Prospective Clinical Study of Camrelizumab Combined With Apatinib Mesylate in the Treatment of Relapsed Platinum-resistant Epithelial Ovarian Cancer
The aim of this study is to explore the effectiveness and safety of camrelizumab combined with apatinib mesylate in the treatment of relapsed platinum-resistant epithelial ovarian cancer
Read the detailed description
The anti-PD-1 drug camrelizumab combined with apatinib mesylate was used to treat relapsed platinum-resistant epithelial ovarian cancer, and the effectiveness and safety of the treatment plan was evaluated by objective remission rate, progression-free survival, and major safety indicators , so as to provide patients a more beneficial treatment plan.
- Conditions
- Immune Checkpoint Inhibition
- Being tested
- Camrelizumab
- Keywords
- camrelizumab, apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called apatinib mesylate
Carmelizumab: Intravenous infusion of a fixed dose of 200 mg in 30 minutes (not less than 20 minutes, not more than 60 minutes), once every 3 weeks, continuous administration until the disease progresses, the patient If death or intolerable toxicity occurs, medication for up to 1 year; Apatinib mesylate tablets: The initial dose is 250 mg, administered once a day, and continue to be administered. If there is a grade 3 to 4 adverse reaction, it should be administered once every other day.
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab+apatinib mesylate | Experimental | Carmelizumab: Intravenous infusion of a fixed dose of 200 mg in 30 minutes (not less than 20 minutes, not more than 60 minutes), once every 3 weeks, continuous administration until the disease progresses, the patient If death or intolerable toxicity occurs, medication for up to 1 year; Apatinib mesylate tablets: The initial dose is 250 mg, administered once a day, and continue to be administered. If there is a grade 3 to 4 adverse reaction, it should be administered once every other day. Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
the proportion of patients with tumor size reduction of a predefined amount
Measured: within 1 year
Secondary outcomes (4)
Progression Free Survival
the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Measured: within 1 year
Disease Control Rate
Refers to the percentage of confirmed complete remission, partial remission and stable disease (≥ 8 weeks) among patients with evaluable efficacy.
Measured: within 1 year
drug safety
Incidence of test drug relative adverse events,Incidence of serious adverse events
Measured: within 1 year
6 months and 12 months overall survival
It is the percentage of people in a study or treatment group still alive for a given period of time after diagnosis
Measured: within 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start10 Aug 2020
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Checkpoint InhibitionStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Jing Liang, Qianfoshan Hospital
- Investigators
- Liang Jing, doctor, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507750
- Sponsor's protocol ID
- XYLL-KY-2020-(028)
- Status last verified
- Sep 2020
- First submitted
- 30 Jul 2020
- Last updated
- 21 Sep 2020
- 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 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective Clinical Study of Camrelizumab Combined With Apatinib Mesylate in the Treatment of Relapsed Platinum-resistant Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04507750
- Acronym / sponsor ID
- XYLL-KY-2020-(028)
- Conditions
- Immune Checkpoint Inhibition
- Keywords
- camrelizumab, apatinib
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 11 Aug 2020 (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.
The aim of this study is to explore the effectiveness and safety of camrelizumab combined with apatinib mesylate in the treatment of relapsed platinum-resistant epithelial ovarian cancer
Detailed description
The anti-PD-1 drug camrelizumab combined with apatinib mesylate was used to treat relapsed platinum-resistant epithelial ovarian cancer, and the effectiveness and safety of the treatment plan was evaluated by objective remission rate, progression-free survival, and major safety indicators , so as to provide patients a more beneficial treatment plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| camrelizumab+apatinib mesylate | Experimental | Drug: CamrelizumabCarmelizumab: Intravenous infusion of a fixed dose of 200 mg in 30 minutes (not less than 20 minutes, not more than 60 minutes), once every 3 weeks, continuous administration until the disease progresses, the patient If death or intolerable toxicity occurs, medication for up to 1 year; Apatinib mesylate tablets: The initial dose is 250 mg, administered once a day, and continue to be administered. If there is a grade 3 to 4 adverse reaction, it should be administered once every other day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age: 18 to 80 years old;
- 2. Histologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer;
- 3. Have received at least two lines of systemic chemotherapy;
- 4. Platinum resistance (disease progression occurs within 6 months after the last platinum-containing chemotherapy Development) or platinum refractory (disease progression during platinum-containing chemotherapy), ovarian cancer,Fallopian tube cancer, primary peritoneal cancer;
- 5. There are measurable lesions (according to RECIST 1.1 standard tumor lesion CT scan long diameter≥10mm, CT scan of lymph node lesions (short diameter≥ 10mm);
Key exclusion criteria (20 listed)
- 1. The subject has any active autoimmune disease or a history of autoimmune disease;
- 2. Severe allergic reaction to other monoclonal antibodies;
- 3. Suffer from other malignant tumors at the same time, except for malignant tumors that have been cured or have stable disease;
- 4. The subject has previously received anti-PD-1, anti-PD-L1, anti-CD137 or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies (including ipilimumab or any other specific targeting T cell Co-stimulation or checkpoint pathway antibodies or drugs) treatment;
- 5. Pregnant or breastfeeding women;
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: apatinib mesylateCarmelizumab: Intravenous infusion of a fixed dose of 200 mg in 30 minutes (not less than 20 minutes, not more than 60 minutes), once every 3 weeks, continuous administration until the disease progresses, the patient If death or intolerable toxicity occurs, medication for up to 1 year; Apatinib mesylate tablets: The initial dose is 250 mg, administered once a day, and continue to be administered. If there is a grade 3 to 4 adverse reaction, it should be administered once every other day. | Drug | camrelizumab+apatinib mesylate |
Primary outcome
Objective response rate
Time frame: within 1 year
the proportion of patients with tumor size reduction of a predefined amount
4 secondary outcomes
Progression Free Survival
Time frame: within 1 year
Disease Control Rate
Time frame: within 1 year
drug safety
Time frame: within 1 year
6 months and 12 months overall survival
Time frame: within 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- 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.
Liang Jing, doctor principal investigator
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camrelizumab in people with Immune Checkpoint Inhibition, run by Qianfoshan 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 11 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 21 Sep 2020. 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.
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 Jing Liang, doctor (+8618663761275, liangjing0531@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: within 1 year). 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 21 Sep 2020.