Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of ES-SCLC

Clinical Study of Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of Extensive Stage Small Cell Lung Cancer

The efficacy of PD-1/PD-L1 combined with chemotherapy in the treatment of extensive small-cell lung cancer is still unsatisfactory. PD-1/PD-L1 combined with chemotherapy and anti-angiogenic drugs may achieve better efficacy.

Study Overview

• Status: Recruiting
• Conditions: Extensive Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Camrelizumab; apatinib; carboplatin; etoposide

Detailed Description

Camrelizumab is a humanized PD-1 monoclonal antibody. Camrelizumab combined with the antiangiogenic drug apatinib has achieved good efficacy in extensive small-cell lung cancer. Median OS is 8.4 months. In our study, subjects with extensive stage small cell lung cancers receive 2 cycles of chemotherapy followed by carrizumab combined with apatinib and chemotherapy. we hope to achieve a better outcome.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ming Liu, MD; Phone Number: 18688380929; Email: mingliu128@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Ming Liu, MD; Phone Number: 18688380929; Email: mingliu128@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Extensive stage small cell lung cancer proved by pathology.
• 2. Extensive small cell lung cancer does not receive systematic treatment.
• 3. limited SCLC patients have received radiotherapy and chemotherapy for more than 6 months.
• 4. patients have measurable lesions according to RECIST version 1.1.
• 5. Male or female who is 18 to 75 years old.
• 6. ECOG PS 0 or 1.
• 7. Life expectancy is more than12 weeks.
• 8. Appropriate organ system function.
• 9. hyroid-stimulating hormone is ULN or less (If T3 and T4 is normal, he still meets the Inclusion Criteria even the abnormal TSH. )
• 10. Take proper contraceptive measures.
• 11. Subjects voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

• 1. Previous treatment with apatinib, anti-programmed cell death (PD-1), anti-PD-1, or other PD-1/ PD-L1 immunotherapy.
• 2. Cancer meningitis.
• 3. patients had been diagnosed and/or treated for other malignancies within 5 years prior to enrollment, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
• 4. There are many factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc..
• 5. Uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage.
• 6. Patients with spinal cord compression who were not cured or relieved by surgery and/or radiotherapy, or who were diagnosed with spinal cord compression after treatment and without clinical evidence of stable disease ≥1 week before enrollment;
• 7. Patients with hypertension who cannot be well controlled by oral antihypertensive therapy, suffer from myocardial ischemia or myocardial infarction of grade I or above, arrhythmias of grade I or above , or cardiac insufficiency;
• 8. Subjects had signs of bleeding, hemoptysis, or a history of unhealed wounds, ulcers, fractures within 2 months prior to initial administration.
• 9. The adverse events caused by previous treatment did not completely recover.
• 10. Patients with major surgery or obvious traumatic injury within 28 days before enrollment;
• 11. Occurred arterial or venous thromboembolism events within 6 months.
• 12. People with a history of drug abuse or mental disorders.
• 13. Suffering from a serious and/or uncontrollable disease;
• 14. Vaccination or attenuated vaccine received within 4 weeks.
• 15. Severe allergies that require treatment with other monoclonal antibody drugs;
• 16. Active autoimmune disease requiring systemic treatment within 2 years prior to the first administration;
• 17. Immunosuppressive therapy with systemic or absorbable local hormones and continued for 2 weeks after the first dose;
• 18. Participate in other anticancer drug clinical trials within 4 weeks;
• 19. In the investigator's judgment, there are other factors that may have led to the termination of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort one; Extensive SCLC patients who are Peripheral type or tumor vascular invasion grade one or less.	Drug: Camrelizumab; apatinib; carboplatin; etoposide; 2 cycle chemotherapy (carboplatin and etoposide), and then 2 cycle chemotherapy (carboplatin and etoposide) combine with Camrelizumab and apatinib, finally maintenance therapy with Camrelizumab and apatinib
Experimental: Cohort two; Extensive SCLC patients who are central type or tumor vascular invasion grade two to three.	Drug: Camrelizumab; apatinib; carboplatin; etoposide; 2 cycle chemotherapy (carboplatin and etoposide), and then 2 cycle chemotherapy (carboplatin and etoposide) combine with Camrelizumab and apatinib, finally maintenance therapy with Camrelizumab and apatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Dose-limiting toxicities	Any level 4 or greater hematologic toxicity and any level 3 or greater non-hematologic toxicity (accroding to CTC AE 5.0)	Followed up every 3 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression Free Survival	Imageological diagnosis every 6 weeks
12 months OS	12 months overall survival	Followed up by telephone every 2 months

Collaborators and Investigators

• Sponsor: Zhou Chengzhi
• Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
• Investigators: Study Director: Chengzhi Zhou, MD, The First Affiliated Hospital of Guangzhou Medical University; Principal Investigator: Xin Chen, MD, Zhujiang Hospital affiliated to Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Anticipated): January 25, 2023
• Study Completion (Anticipated): January 25, 2024

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Camrelizumab; apatinib
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Protein Kinase Inhibitors; Carboplatin; Etoposide; Apatinib
• Other Study ID Numbers: CROC-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No