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Pancreatic CancerPhase 2NCT04415385

The Combination of Camrelizumab and Apatinib as Second-line Therapy for Advanced Pancreatic Carcinoma

A Phase 2 study testing Camrelizumab and Apatinib in people with Pancreatic Cancer, run by Zhejiang Cancer 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is an single arm, open-label, phase II trial to evaluate safety and efficacy of using the combination of Camrelizumab with apatinib as second-line therapy for advanced PDAC. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Camrelizumab and Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
1 Jun 2020to 1 Jun 2023
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily joined the study and signed informed consent. Able to comply with the required protocol and follow-up procedures;
  • Histologically or cytologically confirmed recurrent / metastatic advanced pancreatic cancer, have received gemcitabine or nab-paclitaxel based standard chemotherapy;
  • Male and Female, Age ≥ 18 years and ≤ 70 years;
  • Life expectancy exceeds 3 months;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
  • Patients must have measurable disease per RECIST 1.1;
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  • Subjects with previous systemic therapy completed more than 2 weeks can be enrolled,and the treatment-related AE should be restored to NCI-CTCAE v5.0 less than grade 1 (except for grade 2 hair loss)
  • Subjects with asymptomatic central nervous system metastasis, or asymptomatic brain metastases after treatment, need to be examined by CT or MRI, disease stable for at least 3 months, and at least 4 weeks without steroid medication;
  • Subjects must provide tumor tissue and blood samples for specific index testing;
  • The HBsAg test is negative; if the HBsAg or HBcAb test is positive, the HBV DNA test must be less than 1000 IU / ml;
  • The HCV-Ab test is negative; if the HCV-Ab or HCV-RNA test is positive, ALT and AST CTCAE v5 ≤ 1 level and ≤ 3 × ULN; The joint infection of hepatitis B and C shouled be excluded;
  • Subjects must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment)as determined by: Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 90×109/L ; Total bilirubin ≤ 1×upper limit of normal(ULN)；alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×upper limit of normal(ULN), for subjects with liver metastases, ALT and AST≤5×ULN; Alkaline phosphatase ≤ 2.5 × upper limit of normal(ULN); urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × upper limit of normal(ULN);
  • Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months of the end of the study; the serum or urine pregnancy test is negative within 7 days prior to study enrollment, and Must be non-lactating; males should agree to use contraceptives during the study period and within 6 months of the end of the study period.

Who cannot join

  • There is a third space effusion that cannot be controlled by drainage or other methods (e.g., large amounts of pleural and ascites), and the efficacy of clinical treatment cannot be evaluated;
  • Subjects who are ready to undergo or have previously undergone organ or bone marrow transplantation;
  • Subjects with known active CNS metastases or cancerous meningitis；
  • Surgical and/or radiotherapy failed to radically treated spinal cord compression, or previously diagnosed spinal cord compression did not have clinical evidence for disease stable more than 1 week before the first administration；
  • Imaging examination showed that there was a clear manifestation of tumor invading the abdominal great vessels；
  • Subjects with grade II or above myocardial ischemia, myocardial infarction, unstable angina pectoris and uncontrolled arrhythmia within six months before the first administration;
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  • Subjects with grade III or IV cardiac insufficiency according to the New York Heart Association (NYHA) criteria or color Doppler chocardiography showed left ventricular ejection fraction (LVEF < 50%) ;
  • Peripheral neuropathy with CTCAE V5 ≥ grade II;
  • Human immunodeficiency virus (HIV) infection;
  • Subjects have active pulmonary tuberculosis;
  • Previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc. may interfere with the detection and management of suspected drug-related pulmonary toxicity；
  • Subjects had known active or suspected autoimmune disease.Enrollment was allowed to be stable and did not require systemic immunosuppressive therapy；
  • Subjects received the vaccine within 28 days before the first use of the study drug；
  • Subjects requiring systemic corticosteroids (>10 mg/day prednisone or equivalent doses of the same drug) or other immunosuppressive therapy within 14 days before or during the first dose of the study drug.Enrollment was allowed if inhaled or topical steroids or adrenaline replacement therapy at a dose of <10 mg/day prednisone were allowed in the absence of active autoimmune disease；
  • Any active infection requiring systemic anti-infective treatment occurred within 14 days prior to the first administration of the study drug；
  • Radiotherapy, chemotherapy, surgical treatment or other targeted therapy for pancreatic cancer had been received within 1 week before the first administration of the study drug and had not progressed from previous treatment;
  • Major surgery was performed within 28 days before the first administration. The definition of major surgery in this study is that recovery time of at least 3 weeks after surgery is required to be able to accept the surgery treated in this study.Tumor aspiration or lymph node biopsy allowed enrollment；
  • Subjects received radical radiotherapy within 3 months before the first administration of the study drug;
  • Other anti tumor treatments may be received during the study interval.Such as chemotherapy or radiotherapy (except palliative radiotherapy);
  • Subjects have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody treatment, or any other antibody or T cell co-stimulation drugs or any drugs that target immune checkpoint;
  • Participating in other clinical studies or planning to start this study is less than 14 days from the end of treatment in a previous clinical study;
  • Severe allergy to any monoclonal antibody or study drug excipient;
  • Women who are pregnant or breastfeeding, those with fertility who are unwilling or unable to take effective contraception;
  • Known history of psychotropic drug abuse or drug use. Subjects who have stopped drinking can be enrolled；
  • The investigator judged that the subjects had other factors that could lead to the forced termination of the study.

Trial locations and contacts

1 site in 1 country.

Wangxia Lv, Master contact

+8613757141026

lvwangxia@163.com

China1 site, 1 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Wangxia Lv, Master, +8613757141026, lvwangxia@163.com

    Recruiting

Other trials in China

About this study

Official title: The Combination of Camrelizumab and Apatinib as Second-line Therapy for Advanced Pancreatic Cancer Patients Who Failed Standard First-line Treatment: a Single Arm, Open-label, Phase 2 Study

This is an single arm, open-label, phase II trial to evaluate safety and efficacy of using the combination of Camrelizumab with apatinib as second-line therapy for advanced PDAC.

Read the detailed description

PD-1 antibody Camrelizumab is a humanized monoclonal antibody, and the heavy chain is immunoglobulin G4 (IgG4), the light chain is immunoglobulin κ (IgK). Camrelizumab specifically binds to PD-1 and blocks the interaction of PD-1 with its ligand (PD-L1), allowing T cells to recover against tumor immune responses.

Response rate, progression-free survival, overall survival, duration of response，disease control rate, drugs related side effects were recorded and analyzed, to assess the combination treatment could or couldn't benefit the patients with advanced pancreatic cancer.

Being tested
Camrelizumab, Apatinib
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • CamrelizumabDrug

    Also called SHR-1210

    200mg, intravenous infusion for 30 minutes (including the time of the tube, the overall infusion time is not shorter than 20 minutes, no longer than 60 minutes), once every 2 weeks.

  • ApatinibDrug

    Also called Apatinib Mesylate

    250 mg, orally once a day. Take about half an hour after a meal with warm water.

Study groups in NCT04415385
Study groupRoleWhat they receive
Camrelizumab + ApatinibExperimentalParticipants receive Camrelizumab 200mg intravenously every 2 weeks and apatinib 250mg orally once daily until disease progression or unacceptable toxicity
Receives: Drug: Camrelizumab; Drug: Apatinib

What is being measured

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

  1. ORR

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Measured: Through study completion, an average of 2 years.

Secondary outcomes (5)

  1. PFS

    Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of disease or death from any cause

    Measured: Through study completion, an average of 2 years.

  2. OS

    Overall survival is defined as the duration from date of enrollment to the date of death from any cause.

    Measured: Through study completion, an average of 2 years.

  3. DoR

    DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

    Measured: Through study completion, an average of 2 years.

  4. DCR

    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.

    Measured: Through study completion, an average of 2 years.

  5. Incidence of Adverse Events (AEs) in the treatment of Camrelizumab in combination with apatinib

    Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0

    Measured: Through study completion, an average of 2 years.

Timeline

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

  1. First posted4 Jun 2020
  2. Study start1 Jun 2020 (estimated)
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jun 2023 (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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04415385
Sponsor's protocol ID
ChiECRCT20200088
Status last verified
May 2020
First submitted
29 May 2020
Last updated
4 Jun 2020
Results posted
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 and Apatinib in people with Pancreatic Cancer, run by Zhejiang 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 25 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 4 Jun 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.

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 Wangxia Lv, Master (+8613757141026, lvwangxia@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Through study completion, an average of 2 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 NCT04415385.

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 4 Jun 2020.

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