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

Sponsored by Zhou Chengzhi

About this trial

Last updated 4 years ago

Study ID

CROC-2021

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status

Recruiting