The Combination of Apatinib and Camerlizumab for Advanced Lung Cancer Patients With Muti-line Therapy

NCT ID: NCT04782622

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-03-01

Brief Summary

The combination of Apatinib and Camrelizumab for progressed NSCLC patients with muti-line therapy : a phaseⅠB clinical study.

Brief Summary: Immunotherapy has made a major progress in Lung cancer.However, challenges such as primary and acquired resistance, small fraction of benefit population and lack of predictive and prognostic biomarkers even exist. The overall objective response rate is lower than 20% in second line-treatment and the progression-free survival (PFS) is also similar to or poorer than that of conventional second-line chemotherapy. Apatinib is a novel, orally administered, multitarget receptor tyrosine kinase inhibitor that inhibits VEGFR, PDGFR, FGFR, c-Kit, and other kinases. It functions by inhibiting tumor angiogenesis and proliferative signaling pathways. We would observe and analyze the effectiveness and safety of apatinib combined with Camrelizumab for advanced NSCLC after muti-line therapy to explore the synergistic effect of anti-angiogenic agents and immunotherapy.

Detailed Description

Enrolled patients received apatinib plus Camrelizumab treatment (apatinib, 250mg, qd; Camrelizumab, 5mg/kg, iv, d1, 21day as a cycle.)

Conditions

Lung Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Apatinib+Camrelizumab

treated with apatinib+camrelizumab

Apatinib+Camrelizumab

Intervention Type: DRUG

Apatinib 250mg po qd+Camrelizumab 200mg ivdrip q14d

Interventions

Apatinib+Camrelizumab

Apatinib 250mg po qd+Camrelizumab 200mg ivdrip q14d

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of Lung cancer Ability to comply with protocol Aged ≥ 18 years Histologically documented NSCLC that is currently locally advanced or metastatic NSCLC Disease progression during or following at least one line treatment. Measurable disease, as defined by RECIST v1.1 ECOG performance status of 0 or 1 Life expectancy ≥ 12 weeks Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment: ANC ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) WBC counts > 2.5 × 109/L and < 15 × 109/L Lymphocyte count ≥ 0.5 × 109/L Serum albumin ≥ 2.5 g/dL Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) Hemoglobin ≥ 9.0 g/dL Patients may be transfused or receive erythropoietic treatment to meet this criterion.

Liver function tests meeting one of the following criteria:

AST or ALT ≤ 2.5 × upper limit of normal (ULN), with alkaline phosphatase

≤ 2.5 × ULN or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase > 2.5 × ULN Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert's disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. INR and aPTT ≤ 1.5 × ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. Creatinine clearance ≥ 30 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.

Exclusion Criteria

Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments Leptomeningeal disease Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures Uncontrolled hypertension Perior used anti-angiogenic agents or immune checkpoint inhibitors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

zhangxiaochun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xiaochun Zhang

Qingdao, None Selected, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaochun Zhang

Role: CONTACT

zhangxiaochun9670@126.com

+8653282913271

Facility Contacts

Xiaochun Zhang

Role: primary

zhangxiaochun9670@126.com

+8653282913271

Other Identifiers

ApatPEM

Identifier Type: -

Identifier Source: org_study_id