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

NCT ID: NCT05001412

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2024-01-25

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.

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.

Conditions

Extensive Stage Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort one

Extensive SCLC patients who are Peripheral type or tumor vascular invasion grade one or less.

Group Type: EXPERIMENTAL

Camrelizumab; apatinib; carboplatin; etoposide

Intervention Type: DRUG

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

Cohort two

Extensive SCLC patients who are central type or tumor vascular invasion grade two to three.

Group Type: EXPERIMENTAL

Camrelizumab; apatinib; carboplatin; etoposide

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhou Chengzhi

OTHER

Sponsor Role: lead

Responsible Party

Zhou Chengzhi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chengzhi Zhou, MD

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Guangzhou Medical University

Xin Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital affiliated to Southern Medical University

Locations

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chengzhi Zhou, MD

Role: CONTACT

doctorzcz@163.com

13560351186

Ming Liu, MD

Role: CONTACT

mingliu128@hotmail.com

18688380929

Facility Contacts

Ming Liu, MD

Role: primary

mingliu128@hotmail.com

18688380929

References

Liu M, Qiu G, Guan W, Xie X, Lin X, Xie Z, Zhang J, Qin Y, Du H, Chen X, Deng Y, Li S, Zhong N, Zhou C. Induction chemotherapy followed by camrelizumab plus apatinib and chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: a multicenter, single-arm trial. Signal Transduct Target Ther. 2025 Feb 18;10(1):65. doi: 10.1038/s41392-025-02153-7.

Reference Type: DERIVED

PMID: 39962074 (View on PubMed)

Other Identifiers

CROC-2021

Identifier Type: -

Identifier Source: org_study_id