Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the effect and safty of PD-1 monoclonal antibody-activated autologous peripheral blood T-lymphocyte (PD1-T) combined with docetaxel in the second-line treatment of IIIB/IIIC/IV non-small cell lung cancer. Half of participants receive PD1-T combined with docetaxel, while the other half will receive docetaxel.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: CIK | Experimental | Docetaxel & PD1-T cells Docetaxel,60mg/m2,intravenous infusion,d1; PD1-T cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W. |
|
| Arm 2: Control | Active Comparator | Docetaxel Docetaxel,60mg/m2,intravenous infusion,d1; Q3W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 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. | 3 years |
Not provided
Not provided
Inclusion Criteria:
Subjects who must meet all the following criteria should be selected:
Agreeing to participate in this study and signing a written informed consent.
Male or female,from 18 to 75 years (including 18 and 75 years).
The life expectancy is longer than 3 months and can be followed up.
Patients with stage IIIB/IIIC/IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
According to RECIST 1.1 standard, the researchers evaluated the pre-test imaging to determine the progression of the disease after at least two cycles of platinum-containing double chemotherapies.
ECOG score will be 0 or 1 within 7 days before randomization.
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.
The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).
Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period.
Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.
Exclusion Criteria:
Subjects who meet any of the following criteria could not participate in this study:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiubao Ren, MD. PhD. | Contact | 86-22-23340123 | 3173 | liangcoh@163.com |
| Liang Liu, MD. | Contact | 86-22-23340123 | 3172 | renxiubao@tjmuch.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiubao Ren, MD. PhD. | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PD1-T cells |
| Biological |
PD1-T cells injection |
|
|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |