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Recurrent Platinum-resistant Ovarian CancerPhase 2NCT04068974

Camrelizumab /Apatinib for Recurrent Platinum-resistant Ovarian Cancer

A Phase 2 study testing Camrelizumab (SHR-1210) and Apatinib in people with Recurrent Platinum-resistant Ovarian Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is intend to improve the progression-free survial of the recurrent paltinum-resistant ovarian cancer. All the participants will receive camrelizumab combined with apatinib. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Camrelizumab (SHR-1210) and Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
28 Oct 2019to 30 Jun 2022
Phase
Phase 2
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with recurrent -resistant epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer previously received twice or more platinum chemotherapy before enrolment;
  • Recurrence occurred within 6 months after the last platinum-containing chemotherapy and had experienced at least one platinum-sensitive recurrent in the past.;
  • Aged 18-70 years;
  • An Eastern Cooperative Oncology Group performance status of 0-2;
  • According to the solid tumor efficacy evaluation standard (RECIST1.1) or i RECIST, at least one measurable lesion, with maximum diameter > 1 cm and lymph node metastasis > 1.5 cm, and the target lesion is not suitable for surgical treatment; the target lesion has not received radiotherapy or recurred in the field of radiotherapy.
  • Expected survival ≥ 4 months;
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  • The function of vital organs meets the following requirements： Hemoglobin≥80g/L; Absolute neutrophil count≥1.5*109/L；Platelets≥100
  • 109/L; Creatinine≤1.5 times ULN; Urea nitrogen≤2.5 times ULN; Total Bilirubin≤ULN; ALT and AST ≤ 2.5 times ULN; Albumin≥25g/L; TSH≤ULN(if TSH is abnormal, normal T3 and T4 also can acceptable)
  • The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form.

Who cannot join

  • Primary platinum refractory patients (first platinum-containing chemotherapy with recurrence within 6 months)
  • Previously exposed to other anti-angiogenic small-molecule TKI drugs, such as pazopanib, sorafenib, regorafenib, cilnitraz, etc. or anti-angiogenic mAbs such as bevacizumab ; or had used an anti-PD-1 antibody, an anti-CTLA-4 antibody, TCR-T, CAR-T and other immune therapy; or 4 weeks before the first administration participated in any other clinical trials of anticancer drugs; or before the first dose Live attenuated vaccines are accepted within 4 weeks or during the study period.
  • Target lesions observed received radiotherapy
  • Other malignant tumors have occurred in the past 3 years..
  • Immunosuppressive drugs used within 14 days prior to the first use of SHR-1210, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (ie, no more than 10 mg/day of turmeric or equivalent drug physiological dose) Other corticosteroids).
  • Late-stage patients with symptomatic, disseminated to visceral, short-term risk of life-threatening complications (including uncontrolled large amounts of exudate [thoracic, pericardium, abdominal cavity], pulmonary lymphangitis, and more than 30% liver involvement patients).
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  • Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function; subjects with vitiligo or complete remission asthma in childhood and without any intervention, all above can be included; asthma requiring medical intervention for bronchodilators should be excluded).
  • 8 Metastatic foci of the central nervous system have significant symptoms, such as headache, cerebral edema and blurred vision 9. CT or MRI showed tumor lesion 5mm away from the great blood vessel, or tumor invading the local great blood vessel, or accompanied by tumor thrombus formation of the great vein (inferior vena cava of iliac vessel, superior vena cava of pulmonary static vein) 10. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal medical treatment.
  • 11. Grade II or higher myocardial ischemia, myocardial infarction or poor control arrhythmia (including male with QTc interval ≥ 450ms, or female with QTc interval≥ 470ms). According to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%; myocardial infarction occurred within 6 months before enrollment, New York Heart Association Level II or above failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, pericardial disease with clinically significant, or electrocardiogram suggesting acute ischemia or abnormal active conduction system.
  • 12, Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.
  • 13. Half of a teaspoons (2.5 ml) or more hemoptysis was found within the first 2 months or there were significant clinical bleeding symptoms or clearly propensity bleeding within 3 months before participant in the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ or above in baseline or vasculitis; artery or venous thrombosis events within 6 months prior to the study, such as cerebrovascular accidents (Including transient ischemic attacks, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism.
  • 14. Severe infections within 4 weeks prior to accept medication (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever during screening/first administration >38.5 °C 15. Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders.
  • 16. Major surgical procedures were performed within 4 weeks before the first administration. Or open wounds or fractures.
  • 17. There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction. Or sinus or perforation of empty organs within 6 months.
  • 18. Routine urine test indicated that urinary protein (++) or more, confirmed urinary protein (>1.0 g) within 24 hours.
  • 19. Patients with a history of allergy may be potentially allergic or intolerant to Apatinib and biological agents SHR-1210.
  • 20. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA (> 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of the analysis method) or co-infection with hepatitis B and hepatitis C.
  • 21. There is any situation that may damage the subject or cause the subject to fail to meet or implement the research requirements.

Trial locations and contacts

1 site in 1 country.

Pan Lingya contact

010-69156204

Panly@pumch.cn

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing

    Pan Lingya

    Recruiting

Other trials in China

About this study

Official title: Camrelizumab Combined With Apatinib for Recurrent Platinum-resistant Ovarian Cancer: a Phase 2 Single-arm Prospective Study

This study is intend to improve the progression-free survial of the recurrent paltinum-resistant ovarian cancer. All the participants will receive camrelizumab combined with apatinib.

Being tested
Camrelizumab (SHR-1210), Apatinib
Keywords
Ovarian Cancer, Recurrent Platinum-resistant
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab (SHR-1210)Drug

    Anticancer T-cell activity is regulated by multiple suppressive mechanisms, including tumour-expressed programmed cell death ligand 1 (PD-L1) signalling to the T-cell inhibitory receptor (programmed death protein 1 [PD-1]). Monoclonal antibodies like SHR-1210 that can block this pathway.

  • ApatinibDrug

    Apatinib is an oral small-molecule tyrosine kinase inhibitor that selectively binds to and inhibits VEGF receptor 2.

Study groups in NCT04068974
Study groupRoleWhat they receive
Test groupExperimentalCamrelizumab (SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle. Apatinib :250 mg po qd
Receives: Drug: Camrelizumab (SHR-1210); Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    The proportion of participants with tumor size reduction of a predefined amount and for a minimum time period.

    Measured: Up to two years

Secondary outcomes (4)

  1. Progression Free Survival

    The time from treatment until objective tumor progression or death, whichever occurs first.

    Measured: Up to two years

  2. Disease Control Rate

    The proportion of patients with complete response, partial response or keep stable diease after accept treatment.

    Measured: Up to two years

  3. Duration of Response (DoR)

    The time from firstly complete response or partly response to progressive disease.

    Measured: Up to two years

  4. Assessment of safety

    The quantity and degree of adverse event and serious adverse event from

    Measured: Up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start28 Oct 2019
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04068974
Sponsor's protocol ID
OBU-OvaC-IIT-SHR1210-APA
Status last verified
Mar 2021
First submitted
13 Aug 2019
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab (SHR-1210) and Apatinib in people with Recurrent Platinum-resistant Ovarian Cancer, run by Peking Union Medical College 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 9 inclusion and 18 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 16 Mar 2021. 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 phase mean?

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pan Lingya (010-69156204, Panly@pumch.cn), 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: Up to two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04068974.

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 16 Mar 2021.

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