Clinical trial · Interventional
The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.
The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density: A Prospective Interventional Two-stage Simon Design Phase II Study.
NCT04026841CI-TRIAL-00039866unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Primary Lung Cancers | Malignant Neoplasm of Lung - Multiple Primary Sites | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 antibody Sintilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 Antibody Sintilimab
- description
- Patients receive the treatment of PD-1 antibody Sintilimab
- interventionNames
- Drug: PD-1 antibody Sintilimab
Primary outcomes (1)
- measure
- ORR of target lesions.
- timeFrame
- 3 months
- description
- The objective response rate will be evaluated after 4 courses of treatment
Secondary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 that may lead to the forced termination of this study
References
Publications (0)
Data not yet available
No reference posted for this study.