The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground … (NCT04026841) | Clinical Trial Compass
UnknownPhase 2
The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.
China36 participantsStarted 2019-07-30
Plain-language summary
A single-center,prospective interventional study to explore the efficacy of PD-1 antibody Sintilimab on early-stage multiple primary lung cancer patients with ground-glass nodules in CT scan.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Two or more ground-glass lesions (pure ground glass or partially solid) presented in the CT scan of lung that cannot be operated simultaneously
* There was at least one lung cancer lesion with a diameter of 1-3cm confirmed pathologically or by multidisciplinary team.
* Excluding lymph nodes and distant metastasis through imaging
* ECOG PS 0-1
* Vital organ functions meet the following requirements: 1)The absolute count of neutrophils ≥1.5×109/L 2)Platelet ≥90×109/L 3)Hemoglobin ≥9g/dL 4)Serum albumin ≥3g/dL 5)Thyroid stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be included in the group) 6)Bilirubin ≤ULN 7)ALT and AST≤1.5 ULN 8)AKP≤ 2.5ULN or less 9)Serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min
* Subjects volunteered to participate in this study and signed informed consent, with good compliance.
Exclusion Criteria:
* Non-calcified lesions with diameter more than 3mm are presented
* The presence of any active autoimmune diseases or a history of autoimmune diseases
* Those who have used other drugs in clinical study within 4 weeks before the first time of drug use
* Severe allergic reaction to monoclonal antibody
* Heart clinical symptoms or diseases are not well controlled
* Subjects with congenital or acquired immune deficiency (such as HIV infection) or active hepatitis
* According to the researcher's judgment, the subjects have other factors t…
What they're measuring
1
ORR of target lesions.
Timeframe: 3 months
Trial details
NCT IDNCT04026841
SponsorThe First Affiliated Hospital of Guangzhou Medical University