The Efficacy of PD-1 Antibody Sintilimab on Early-stage Multiple Primary Lung Cancer With Ground Glass Density.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04026841 |
Recruitment Status :
Recruiting
First Posted : July 19, 2019
Last Update Posted : August 2, 2019
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Condition or disease | Intervention/treatment | Phase |
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Multiple Primary Lung Cancers | Drug: PD-1 antibody Sintilimab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Clinical trials with a single arm |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Actual Study Start Date : | July 30, 2019 |
Estimated Primary Completion Date : | February 1, 2020 |
Estimated Study Completion Date : | February 1, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: PD-1 Antibody Sintilimab
Patients receive the treatment of PD-1 antibody Sintilimab
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Drug: PD-1 antibody Sintilimab
Patients in experimental group receive the treatment of PD-1 antibody Sintilimab |
- ORR of target lesions. [ Time Frame: 3 months ]The objective response rate will be evaluated after 4 courses of treatment
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 3 months ]The safty of PD-1 Antibody Sintilimab

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026841
Contact: Jianxing He, MD | +86-02-83062808 | hejx@vip.163.com | |
Contact: Wenhua Liang, PhD | +86-02-83062808 | liangwh1987@163.com |
China, Guangdong | |
Department of Thoracic Surgery and Oncology, The First Affiliated Hospital of Guangzhou Medical University | Recruiting |
Guangzhou, Guangdong, China | |
Contact: Wenhua Liang, PhD 0086-20-83062114 liangwh1987@163.com | |
Contact: Wenhua Liang, PhD |
Principal Investigator: | Jianxing He, MD | The First Affiliated Hospital of Guangzhou Medical University |
Responsible Party: | Jianxing He, professor, The First Affiliated Hospital of Guangzhou Medical University |
ClinicalTrials.gov Identifier: | NCT04026841 |
Other Study ID Numbers: |
CCTC1901 |
First Posted: | July 19, 2019 Key Record Dates |
Last Update Posted: | August 2, 2019 |
Last Verified: | July 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ground-glass nodule ground-glass density |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Antibodies Immunologic Factors Physiological Effects of Drugs |