NCT05400070Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 18 Oct 2024
Brief summary (registry, in English)
primary purpose:Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 18 May 2022
- Start date
- 1 Mar 2021
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Tang-Du Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05400070
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 45
- From 1 Mar 2021 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 6.Patients who have previously received chemotherapy or any other anti-tumor therapy;
Other illness
- 1 . Presof locally advanced unresectable or metastatic disease;
- 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;
- 5.Active Hepatitis B / hepatitis C infection and known HIV;
Other
- 2.. peripheral neuropathy;
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tangdu Hospital, the Air Force Military University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.