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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04967625
Other study ID # ZJCH-SCLC-01
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 26, 2021
Est. completion date December 31, 2023

Study information

Verified date March 2021
Source Zhejiang Cancer Hospital
Contact Lan Shao
Phone +86 13456964958
Email shaolan28@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a the researchers launched, single-center, prospective, open-label, single arm ,Phase II clinical study of Sintilimab combined with anlotinib in patients with extensive-stage disease small-cell lung cancer to evaluate the efficacy and safety. 23 patients are expected to be enrolled in this study.


Description:

Subjects will receive sintilimab 200mg, IV, Q3W and anlotinib 12mg, PO, QD,d1-14, Q3W treatment until disease progression, unacceptable toxicity, or death.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 23
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged = 18, regardless of gender . - Histologically or cytologically confirmed small cell lung cancer . - The time after the end of first-line treatment was less than 6 months . - Subjects must have measurable diseases as defined in RECIST v1.1 . - Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-2 . - Adequate hematologic and end organ function . - Capable of understanding the trial nature and voluntarily signing the written informed consent form . Exclusion Criteria: - Radiographic findings showed that the tumor involved large blood vessels or was poorly demarcated from them . - Radiographic findings showed significant pulmonary cavitation or necrotizing tumor . - Active brain metastasis or meningeal metastasis . - With other malignant tumors in the past 5 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, or carcinoma cervix in situ . - With Interstitial lung disease, including drug- induced Interstitial lung disease or radiation pneumonitis . - With clinically significant cardiovascular disorder . - Prior exposure to any immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies . - Prior exposure to anti-VEGFR therapy . - Known hypersensitivity to study drug or any of its excipients . - Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to first administration . - Other conditions that the investigator thinks unsuitable in this study .

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sintilimab
A humanized anti-PD-1 monoclonal antibody
Anlotinib hydrochloride
A tyrosine kinase inhibitor selectively targeting VEGFR-2

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang Cancer Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary ORR Objective response rate according to RECIST v1.1 12 month
Secondary DCR Disease control rate according to RECIST v1.1 12 months
Secondary DoR Duration of response according to RECIST v1.1 12 months
Secondary PFS Progression-free survival according to RECIST v1.1 12 months
Secondary OS Overall survival on average of 2 years
Secondary Adverse Event Evaluation of adverse event rate according to CTCAE v4.03 12 months
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