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

Sponsor

Zhou Chengzhi (Other)

Overall Status

Recruiting

CT.gov ID

NCT05001412

Collaborator

Jiangsu Hengrui Pharmaceutical Co., Ltd. (Industry)

Enrollment

Location

Arms

35.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Extensive Stage Small Cell Lung Cancer	Drug: Camrelizumab; apatinib; carboplatin; etoposide	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

We divide them into two cohorts based on the extent of tumor invasion to the mediastinum or hilar large vesselsWe divide them into two cohorts based on the extent of tumor invasion to the mediastinum or hilar large vessels

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 27, 2021

Anticipated Primary Completion Date :

Jan 25, 2023

Anticipated Study Completion Date :

Jan 25, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

PFS [Imageological diagnosis every 6 weeks]
Progression Free Survival
12 months OS [Followed up by telephone every 2 months]
12 months overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Extensive stage small cell lung cancer proved by pathology.
1. Extensive small cell lung cancer does not receive systematic treatment.
1. limited SCLC patients have received radiotherapy and chemotherapy for more than 6 months.
1. patients have measurable lesions according to RECIST version 1.1.
1. Male or female who is 18 to 75 years old.
1. ECOG PS 0 or 1.
1. Life expectancy is more than12 weeks.
1. Appropriate organ system function.
1. hyroid-stimulating hormone is ULN or less (If T3 and T4 is normal, he still meets the Inclusion Criteria even the abnormal TSH. )
1. Take proper contraceptive measures.
1. 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.
1. Cancer meningitis.
1. 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.
1. There are many factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc..
1. Uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage.
1. 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;
1. 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;
1. Subjects had signs of bleeding, hemoptysis, or a history of unhealed wounds, ulcers, fractures within 2 months prior to initial administration.
1. The adverse events caused by previous treatment did not completely recover.
1. Patients with major surgery or obvious traumatic injury within 28 days before enrollment;
1. Occurred arterial or venous thromboembolism events within 6 months.
1. People with a history of drug abuse or mental disorders.
1. Suffering from a serious and/or uncontrollable disease;
1. Vaccination or attenuated vaccine received within 4 weeks.
1. Severe allergies that require treatment with other monoclonal antibody drugs;
1. Active autoimmune disease requiring systemic treatment within 2 years prior to the first administration;
1. Immunosuppressive therapy with systemic or absorbable local hormones and continued for 2 weeks after the first dose;
1. Participate in other anticancer drug clinical trials within 4 weeks;
1. In the investigator's judgment, there are other factors that may have led to the termination of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China	510120

Sponsors and Collaborators

Zhou Chengzhi
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