Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer First-line Treatment | Biological: CIK cell Biological: Sintilimab Injection Drug: Pemetrexed Drug: Liposome paclitaxel Drug: Carboplatin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Clinical Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the First-line Treatment of IIIB/IIIC/IV Non-Small Cell Lung Cancer |
Actual Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | June 1, 2021 |
Estimated Study Completion Date : | June 1, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm: CIK+PD-1 inhibitor+chemotherapy
CIK cell, IBI308, Pemetrexed, Liposome paclitaxel, Carboplatin IBI308 intravenous infusion 200mg d1; Pemetrexed intravenous infusion 500mg/m2 d2 or Liposome paclitaxel intravenous infusion 135mg/m2 d2; Carboplatin intravenous infusion AUC5 d2; CIK cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W. |
Biological: CIK cell
CIK cell injection
Other Name: Autologous cytokine-induced killer cells
Biological: Sintilimab Injection IBI308 injection
Other Name: PD-1 inhibitor
Drug: Pemetrexed Pemetrexed injection
Drug: Liposome paclitaxel Liposome paclitaxel injection
Drug: Carboplatin Carboplatin injection
|
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects who must meet all the following criteria should be selected:
Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria:
White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range.
Exclusion Criteria:
Subjects who meet any of the following criteria could not participate in this study:
Contact: Xiubao Ren, MD. PhD. | 86-22-23340123 ext 3173 | liangcoh@163.com | |
Contact: Liang Liu, MD. Ph.D | 86-22-23340123 ext 3172 | renxiubao@tjmuch.com |
China, Tianjin | |
Tianjin Medical University Cancer Institute and Hospital | Recruiting |
Tianjin, Tianjin, China, 300060 | |
Contact: Liang Liu, MD. Ph.D 86-22-23340123 ext 3172 liangcoh@163.com | |
Contact: Xiubao Ren, MD. PhD. 86-22-23340123 ext 3173 renxiubao@tjmuch.com |
Study Chair: | Xiubao Ren, MD. PhD. | Tianjin Medical University Cancer Institute and Hospital |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | June 12, 2019 | ||||||||
First Posted Date ICMJE | June 17, 2019 | ||||||||
Last Update Posted Date | July 7, 2020 | ||||||||
Actual Study Start Date ICMJE | June 1, 2019 | ||||||||
Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Objective response rate (ORR) [ Time Frame: 2 years ] ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR).
|
||||||||
Original Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: 2 years ] PFS will be calculated from initiation of treatment until first progression, and patients alive in stable state will be censored at the time of last contact.
|
||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the Advanced NSCLC | ||||||||
Official Title ICMJE | Phase I Clinical Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the First-line Treatment of IIIB/IIIC/IV Non-Small Cell Lung Cancer | ||||||||
Brief Summary | This prospective, unicentric, open-labe phase I study is to evaluate the effects of autologous cytokine-induced killer cell immunotherapy combination with PD-1 inhibitor and chemotherapy in the first-line treatment of IIIB/IIIC/IV non-small cell lung cancer. | ||||||||
Detailed Description | In the non-squamous NSCLC, patients received sintilimab Injection (PD-1 inhibitor) 200mg, d1; pemetrexed injection 500mg/m2, d1; carboplatin injection AUC 5, d1; CIK cells venous re-transfusion >=1x10^10, d14; Q3W, for 4 cycles. Then sintilimab and pemetrexed maintenance treatment for 2 years. In the squamous NSCLC, patients received sintilimab Injection (PD-1 inhibitor) 200mg, d1; liposome paclitaxel injection 135mg/m2, d1; carboplatin injection AUC 5, d1; CIK cells venous re-transfusion >=1x10^10, d14; Q3W, for 4 cycles. Then sintilimab maintenance treatment for 2 years. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE |
|
||||||||
Study Arms ICMJE | Experimental: Arm: CIK+PD-1 inhibitor+chemotherapy
CIK cell, IBI308, Pemetrexed, Liposome paclitaxel, Carboplatin IBI308 intravenous infusion 200mg d1; Pemetrexed intravenous infusion 500mg/m2 d2 or Liposome paclitaxel intravenous infusion 135mg/m2 d2; Carboplatin intravenous infusion AUC5 d2; CIK cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W. Interventions:
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
30 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 1, 2021 | ||||||||
Estimated Primary Completion Date | June 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Subjects who must meet all the following criteria should be selected:
Exclusion Criteria: Subjects who meet any of the following criteria could not participate in this study:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03987867 | ||||||||
Other Study ID Numbers ICMJE | E2019091A | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Tianjin Medical University Cancer Institute and Hospital | ||||||||
Study Sponsor ICMJE | Tianjin Medical University Cancer Institute and Hospital | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | Tianjin Medical University Cancer Institute and Hospital | ||||||||
Verification Date | July 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |