Cryoablation Combined With Camrelizumab and Apatinib for Multiprimary Lung Cancer

NCT04201990 | Unknown Phase 1

• 1 other identifier: 2019-62
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: This study is to observe the safety and therapeutic effect of cryoablation combined with pd-1 antibody immunotherapy and anti-angiogenesis therapy in multiple primary lung cancer (MPLC) patients. Methods: In this study, 20 patients with MPLC who conform to the admission criteria are enrolled and began to receive treatment with Camrelizumab combined with Apatinib after cryoablation.

Conditions

Lung Cancer

Keywords

MPLC; Camrelizumab; Apatinib

Outcome Measures

Primary Outcomes (1)

• Safety score

  The occurrence of grade 3 to 5 adverse reactions was assessed by CTC AE v5.0

  three weeks

Secondary Outcomes (5)

• ORR

  six weeks

• DCR

  six weeks

• PFS

  six weeks

• OS

  six weeks

• DOR

  six weeks

Other Outcomes (1)

• biomarker

  three months

Study Arms (1)

treatment group

EXPERIMENTAL

Camrelizumab, iv, Q3W until progression disease or intolerable toxicity or 2 years Apatinib, po, QD until progression disease or intolerable toxicity or 2 years

Drug: Camrelizumab and Apatinib

Interventions

Camrelizumab and Apatinib DRUG

Camrelizumab, iv, Q3W; Apatinib, po, QD

Also known as: cryoablation

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical and pathological diagnosis of muitiple primary lung cancer.
• more than three pulmonary nodules and without lymph node metastasis.
• the maximum lesion less than three centimeters in diameter.
• No more than one operation, and remains more than two pulmonary nodules which pathological confirmed were MIA or AIS.
• at least one measurable lesion conforming to RECIST v1.1 standard was left after cryotherapy.
• male or female, age 18 to 75 years old.
• the ECOG PS score was 0 or 1.
• expected survival is more than 12 weeks.
• functions of vital organs and bone marrow meet the following requirements: A. ANC ≥1.5× 109/L, PLT ≥100× 109/L, HGB ≥9 g/dL; B. TBIL ≤1.5 ULN, ALT and/or AST ≤2.5 ULN, ALB ≥2.8 g/dL; C. Cr ≤1.5× ULN, or creatinine clearance rate ≥40 mL/min
• subject and subject's sexual partner shall use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
• subject must sign theinformed consent.

You may not qualify if:

• patients with EGFR mutations and ALK rearrangement.
• cannot be treated with cryoablation: diffuse lesions in both lungs, extensive pleural metastasis with large amount of pleural effusion, tumor adjacent to mediastinal large vessels or surrounding large vessels.
• have previously received anti-pd-1, anti-pd-l1, anti-ctla-4 antibodies or any other antibodies or drugs that target T cell co-stimulation or immune checkpoint pathways.
• received the following treatment Within four weeks before enrollment:
• received systemic anti-tumor therapy, such as chemotherapy, targeted therapy and immunotherapy;
• receive any investigational medication;
• receive a large dose of immunosuppressive drugs (systemic glucocorticoid exceeding 10 mg/ temprednisone or its equivalent);
• receive live attenuated vaccine;
• major surgery or unhealed surgical wounds, ulcers, or fractures.
• known or suspected active autoimmune diseases (congenital or acquired).
• allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
• allergy to any component of monoclonal antibody preparation.
• interstitial lung disease.
• suffering from other uncontrolled serious diseases, including but not limited to:
• severe infections in the active phase or with poor clinical control;

Sponsors & Collaborators

• ShiYue Li: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

camrelizumab; apatinib; Cryosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Shiyue Li, MD

CONTACT

8620-83062896; lishiyue@188.com

Ming Liu, MD

CONTACT

mingliu128@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of Guangzhou Institute of Respiratory Disease

Model Details: About two to three weeks after cryoablation, Eligible patients sign informed consent and then begin treating with Camrelizumab and Apatinib.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 17, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: December 17, 2019

Record last verified: 2019-12