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

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country90 target enrollmentJune 1, 2019

ConditionsRenal Cell Carcinoma Clear Cell Renal Cell Carcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Renal Cell Carcinoma
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 90
Locations: 1
Primary Endpoint: Progression-free survival
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

In the experimental group, patients received Camrelizumab injection (SHR-1210) 200mg d1, CIK cells 1x10\^10 d14; Q3W, for 4 cycles; then Camrelizumab injection maintenance treatment for 2 years. In the control group, patients received Camrelizumab injection 200mg d1, Q3W, for 2 years.

Registry

clinicaltrials.gov

Start Date

June 1, 2019

End Date

June 1, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

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 will be longer than 3 months and can be followed up.
•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.
•Patients with disease progression after treatment with interferon or TKI.
•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).

Exclusion Criteria

•Subjects who meet any of the following criteria could not participate in this study:
•Other malignant tumors needed treatment within five years.
•Allogeneic tissue/organ transplantation.
•Participating in research drug therapy within 4 weeks before the first administration of the trial.
•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.
•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.
•Previous treatment with PD-1/PD-L1 antibodies.
•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.
•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.
•Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.

Outcomes

Primary Outcomes

Progression-free survival

Time Frame: 3 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.