Clinical trial NCT05001412: Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of ES-SCLC
Official title: Clinical Study of Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Extensive Stage Small Cell Lung Cancer
Keywords: Camrelizumab; apatinib
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
Collaborators: name: Jiangsu Hengrui Pharmaceutical Co., Ltd.
First posted: 2021-08-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We divide them into two cohorts based on the extent of tumor invasion to the mediastinum or hilar large vessels
Primary purpose: TREATMENT

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.

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.
* 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.

Primary outcomes:
measure: Safety: Dose-limiting toxicities
timeFrame: Followed up every 3 weeks.
Secondary outcomes:
measure: PFS
timeFrame: Imageological diagnosis every 6 weeks
measure: 12 months OS
timeFrame: Followed up by telephone every 2 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Chengzhi Zhou, MD
role: STUDY_DIRECTOR
affiliation: Zhujiang Hospital affiliated to Southern Medical University
name: Xin Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: