The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.

NCT04026841 | Unknown Phase 2

• 1 other identifier: CCTC1901
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Primary Lung Cancers

Keywords

ground-glass nodule; ground-glass density

Outcome Measures

Primary Outcomes (1)

• ORR of target lesions.

  The objective response rate will be evaluated after 4 courses of treatment

  3 months

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  3 months

Study Arms (1)

PD-1 Antibody Sintilimab

EXPERIMENTAL

Patients receive the treatment of PD-1 antibody Sintilimab

Drug: PD-1 antibody Sintilimab

Interventions

PD-1 antibody Sintilimab DRUG

Patients in experimental group receive the treatment of PD-1 antibody Sintilimab

PD-1 Antibody Sintilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Study Officials

• Jianxing He, MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxing He, MD

CONTACT

+86-02-83062808; hejx@vip.163.com

Wenhua Liang, PhD

CONTACT

+86-02-83062808; liangwh1987@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Clinical trials with a single arm

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: July 30, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: August 2, 2019

Record last verified: 2019-07

Locations

CN (1)