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

NCT05001412 | Unknown Phase 1

• 1 other identifier: CROC-2021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

Camrelizumab; apatinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PFS

  Imageological diagnosis every 6 weeks

• 12 months OS

  Followed up by telephone every 2 months

Study Arms (2)

Cohort one

EXPERIMENTAL

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

Drug: Camrelizumab; apatinib; carboplatin; etoposide

Cohort two

EXPERIMENTAL

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

Drug: Camrelizumab; apatinib; carboplatin; etoposide

Interventions

Camrelizumab; apatinib; carboplatin; etoposide 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 one; Cohort two

Eligibility Criteria

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

You may qualify if:

• \. Extensive stage small cell lung cancer proved by pathology.
• \. Extensive small cell lung cancer does not receive systematic treatment.
• \. limited SCLC patients have received radiotherapy and chemotherapy for more than 6 months.
• \. patients have measurable lesions according to RECIST version 1.1.
• \. Male or female who is 18 to 75 years old.
• \. ECOG PS 0 or 1.
• \. Life expectancy is more than12 weeks.
• \. Appropriate organ system function.
• \. Take proper contraceptive measures.
• \. Subjects voluntarily participate in this study and sign the informed consent.

You may not qualify if:

• \. Previous treatment with apatinib, anti-programmed cell death (PD-1), anti-PD-1, or other PD-1/ PD-L1 immunotherapy.
• \. Cancer meningitis.
• \. 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.
• \. There are many factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc..
• \. Uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage.
• \. 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;
• \. 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;
• \. Subjects had signs of bleeding, hemoptysis, or a history of unhealed wounds, ulcers, fractures within 2 months prior to initial administration.
• \. The adverse events caused by previous treatment did not completely recover.
• \. Patients with major surgery or obvious traumatic injury within 28 days before enrollment;
• \. Occurred arterial or venous thromboembolism events within 6 months.
• \. People with a history of drug abuse or mental disorders.
• \. Suffering from a serious and/or uncontrollable disease;
• \. Vaccination or attenuated vaccine received within 4 weeks.
• \. Severe allergies that require treatment with other monoclonal antibody drugs;

Sponsors & Collaborators

• Zhou Chengzhi: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39962074 DERIVED

MeSH Terms

Interventions

camrelizumab; apatinib; Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Chengzhi Zhou, MD

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

• Xin Chen, MD

  Zhujiang Hospital affiliated to Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengzhi Zhou, MD

CONTACT

13560351186; doctorzcz@163.com

Ming Liu, MD

CONTACT

18688380929; mingliu128@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 12, 2021
• Study Start: January 27, 2021
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2024
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)