NCT05825443RecruitingPhase 2
Adjuvant Chemotherapy Combined With Camrelizumab for ⅡA -ⅢA NSCLC Patients
Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With ⅡA -ⅢA Non-small Cell Lung Cancer:a Phase II , Single-arm Clinical Study
Source: ClinicalTrials.gov · Last updated 25 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (estimated)
- First submitted
- 2 Mar 2023
- Start date
- 10 Apr 2023
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Lung cancer
- NCT number
- NCT05825443
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 57
- From 10 Apr 2023 to the primary completion date, 1 Apr 2026
- 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
- Myocardial infarction, unstable angina pectoris and grade II congestive heart failure in six months before enrollment; New angina pectoris occurred within 3 months; Ventricular arrhythmia requiring medication;
- Uncontrolled hypertension after treatment with antihypertensive drugs, i.e. systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg;
- Allogeneic organ transplantation;
- Thrombotic or embolic venous or arterial events occurred within six months before enrollment;
- Participate in other clinical studies within 3 months before enrollment;
Other illness
- Known or suspected to be allergic to the drug or any component of the drug related to the test;
- Other malignant tumors in five years before enrollment, excluding the cured cervical carcinoma in situ, the cured skin basal cell carcinoma, and other types of tumors that were cured only after surgical treatment;
- History of HIV infection, active period of HCV infection, active period of HBV infection (HBV-DNA\>1000 copies/ml);
- The researcher judged that there was a risk of bleeding;
- Active severe clinical infection (≥ grade 3 CTCAE V5.0);
- Epilepsy patients who need medication;
- Any malabsorption disease;
- Any disease that is unstable or may endanger the patient's safety;
- Drug abuse, medical, psychological or social diseases;
Other
- Patients who can receive targeted treatment;
- Patients who need kidney dialysis;
- Serious uncured wounds, ulcers or fractures;
- Interstitial pneumonia;
- During pregnancy or lactation;
Who the study is looking for
- Sign the informed consent form before starting the study;
- For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;
- Patients cannot receive targeted adjuvant therapy;
- 18-80 years old;
- The patient can recover within 3-8 weeks after the operation, and receive postoperative adjuvant treatment;
- The ECOG PS score is 0 or 1;
- Have not received any chemotherapy for non-small cell lung cancer before enrollment;
- Within 7 days before enrollment, the laboratory inspection must meet all the following requirements:
- Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 9g/dL;
- Total bilirubin ≤ 1.5 ULN; AST and ALT ≤ 2.5 ULN;
- Serum creatinine ≤ 1.25 ULN, or serum creatinine clearance ≥ 60ml/min;
- Female patients must meet: menopause or have undergone surgical sterilization. Women with fertility must take effective contraceptive measures. Do not breastfeed.
- Male patients must agree to use appropriate contraceptive measures.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept 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 |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guandong | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.