Neoadjuvant PD-1 Inhibitor (Sintilimab), Anlotinib Combined With Chemotherapy in Resectable Stage IIA-IIIB NSCLC
A Single-arm Clinical Study to Investigate the Efficacy and Safety of Neoadjuvant PD-1 Inhibitor (Sintilimab), Anlotinib Combined With Chemotherapy in Resectable Stage IIA-IIIB NSCLC
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
primary purpose：Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.
Description of the study design This is a single-center, prospective, open-label, single-arm clinical study to preliminarily explore the single-arm clinical study administration and drug management of Sintilimab, anlotinib combined with neoadjuvant chemotherapy in stage IIA-IIIB NSCLC
Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Xi'an, China, 710038
- Tangdu hospital, The air force military university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- pathological diagnosis of lung cancer, Age 18 years and 75 years old, physical strength status score 0-1;
- The investigator believes that the subject can comply with the study protocol;
- The investigator has confirmed to have at least one measurable lesion according to the RECIST1.1 criteria;
- Stage IIA, IIB, IIIA, IIIB NSCLC with histological or cytology proven operable treatment according to the International Association for Lung Cancer Research and the American Joint Committee on Cancer Staging version 8;
- Good hematopoietic function, defined as absolute neutrophil number 1.5X109 / L (no granulocyte colony stimulating factor support therapy), platelet count 100X109 / L, hemoglobin 90 g / L; (no transfusion or no erythropoietin dependence within 7 days);
- Good liver function, defined as 1.5 times the normal limit (ULN) of serum total bilirubin; ULN at 2.5 times transaminase (AST) and ALT); AST and ALT for recorded ULN;
- Good renal function, defined as serum creatinine 1.5 times ULN or calculated creatinine clearance of 60 ml/min (Cockcroft-Gault formula); routine urine protein less than 2 +, or 24h urine protein <1g;
- Good coagulation function, defined as the international standardized ratio (INR) or prothrombin time (PT) 1.5 times ULN;
- The total amount of lung function (e. g., FVC, FEV1, TLC, FRC, and DLco) can tolerate the proposed lung resection procedure;
- For female subjects of childbearing age, the urine or serum pregnancy test should be negative within 3 days before receiving the first dose (cycle 1, day 1)
Exclusion Criteria:
1 . Presof locally advanced unresectable or metastatic disease;
2.. peripheral neuropathy;
3.Active, known or suspected autoimmune diseases, type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or diseases not expected to recur without external stimulus factors can be selected;
4. Systemic treatment with corticosteroids (an equivalent dose of> 10 mg prednisone per day) or other immunosuppressive drugs within 14 days before randomization.Inhalor topical steroids are permitted without active autoimmune disease.
5.Active Hepatitis B / hepatitis C infection and known HIV;
6.Patients who have previously received chemotherapy or any other anti-tumor therapy;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: neoadjuvant therapy
Sintilimab (200mg fixed dose) iv, d1, q3w，anlotinib 10mg, po, qd1-14, q3w combine with Chemotherapy
|
Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pathological complete response (PCR)
Time Frame: up to 4 months
|
pathological complete response (PCR)
|
up to 4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K202104-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.