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Study of PD-1 Inhibitor Combination With Autologous Cell Immunotherapy in the Metastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03987698
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

Brief Summary:
This randomized, multicenter,open-label phase II study is to evaluate the effects of PD-1 inhibitor combination with autologous cytokine-induced killer cell immunotherapy in the second-line treatment of patients with metastatic clear cell renal cell carcinoma.

Condition or disease Intervention/treatment Phase
Metastic Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma Second-line Treatment Biological: SHR-1210 Biological: CIK cells Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of PD-1 Monoclonal Antibody Combination With Autologous Cytokine-induced Killer Cell Immunotherapy in the Second-line Treatment of Metastatic Clear Cell Renal Cell Carcinoma
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 1: CIK+PD-1i

SHR-1210 & CIK cells

SHR-1210,200mg/d,intravenous infusion,d1; CIK cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W.

Biological: SHR-1210
SHR-1210 injection
Other Name: PD-1 inhibitor

Biological: CIK cells
CIK cells injection
Other Name: Cytokine-induced killer cells

Active Comparator: Arm 2: Control
SHR-1210,200mg/d,intravenous infusion,d1; Q3W.
Biological: SHR-1210
SHR-1210 injection
Other Name: PD-1 inhibitor




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 year ]
    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.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects who must meet all the following criteria should be selected:

  1. Agreeing to participate in this study and signing a written informed consent.
  2. Male or female,from 18 to 75 years (including 18 and 75 years).
  3. The life expectancy will be longer than 3 months and can be followed up.
  4. Patients with metastatic clear cell renal cell carcinoma were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
  5. Patients with disease progression after treatment with interferon or TKI.
  6. ECOG score will be 0 or 1 within 7 days before randomization.
  7. 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.

  8. The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).
  9. 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.
  10. 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:

  1. Other malignant tumors needed treatment within five years.
  2. Allogeneic tissue/organ transplantation.
  3. Participating in research drug therapy within 4 weeks before the first administration of the trial.
  4. Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy.
  5. Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug.
  6. Previous treatment with PD-1/PD-L1 antibodies.
  7. Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment.
  8. Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA > 10^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method.
  9. Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.
  10. Patients with active infections requiring systemic intravenous therapy.
  11. Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
  12. Subjects who are known to be allergic to any of the constituents of the drug being studied.
  13. Subjects with a recent history of drug abuse (including alcohol) within one year.
  14. Compliance is poor and can not cooperate with clinical research.
  15. Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.

Information from the National Library of Medicine

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): NCT03987698


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
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Study Chair: Xiubao Ren, MD. PhD. Tianjin Medical University Cancer Institute and Hospital

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03987698     History of Changes
Other Study ID Numbers: E2017232
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases