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

NCT04415385 | Unknown Phase 2

• 1 other identifier: ChiECRCT20200088
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (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

  Through study completion, an average of 2 years.

Secondary Outcomes (5)

• PFS

  Through study completion, an average of 2 years.

• OS

  Through study completion, an average of 2 years.

• DoR

  Through study completion, an average of 2 years.

• DCR

  Through study completion, an average of 2 years.

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

  Through study completion, an average of 2 years.

Study Arms (1)

Camrelizumab + Apatinib

EXPERIMENTAL

Participants receive Camrelizumab 200mg intravenously every 2 weeks and apatinib 250mg orally once daily until disease progression or unacceptable toxicity

Drug: Camrelizumab; Drug: Apatinib

Interventions

Camrelizumab DRUG

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.

Also known as: SHR-1210

Camrelizumab + Apatinib

Apatinib DRUG

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

Also known as: Apatinib Mesylate

Camrelizumab + Apatinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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；

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Wangxia Lv, Master

CONTACT

+8613757141026; lvwangxia@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)