Renal Cell CarcinomaPhase 2NCT03987698
Study of PD-1 Inhibitor Combination With Autologous Cell Immunotherapy in the Metastatic Renal Cell Carcinoma
A Phase 2 study testing SHR-1210 and CIK cells in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma
- What is being tested?
- SHR-1210 and CIK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Patients with active infections requiring systemic intravenous therapy.
- Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
- Subjects who are known to be allergic to any of the constituents of the drug being studied.
- Subjects with a recent history of drug abuse (including alcohol) within one year.
- Compliance is poor and can not cooperate with clinical research.
- Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Liang Liu, MD. Ph.D, 86-22-23340123 ext. 3172, liangcoh@163.com
Xiubao Ren, MD. PhD., 86-22-23340123 ext. 3173, renxiubao@tjmuch.com
About this study
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
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.
Read the 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.
- Being tested
- SHR-1210, CIK cells
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Biological
Also called PD-1 inhibitor
SHR-1210 injection
CIK cellsBiological
Also called Cytokine-induced killer cells
CIK cells injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: CIK+PD-1i | Experimental | SHR-1210 \& CIK cells
SHR-1210,200mg/d,intravenous infusion,d1; CIK cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W. Receives: Biological: SHR-1210; Biological: CIK cells |
| Arm 2: Control | Active comparator | SHR-1210,200mg/d,intravenous infusion,d1; Q3W. Receives: Biological: SHR-1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Jun 2019
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiubao Ren, MD. PhD., Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987698
- Sponsor's protocol ID
- E2017232
- Status last verified
- Jul 2020
- First submitted
- 12 Jun 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li S, Qin J, Sun Q, Zhao H, Xiong Y, Wang Y, Han Y, Zhang J, Zhang W, Shen M, Yang F, Ren B, Zhou L, Li R, Hui Z, Tian X, Cao S, Du W, Yu W, Liu L, Zhang X, Ren X. Randomized pilot study of camrelizumab with or without autologous cytokine-induced killer cells in refractory clear cell renal cell carcinoma. Sci Rep. 2026 Feb 7;16(1):7768. doi: 10.1038/s41598-026-38881-1.
PubMed 41654611
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03987698
- Acronym / sponsor ID
- E2017232
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CIK+PD-1i | Experimental | Biological: SHR-1210, Biological: CIK cellsSHR-1210 \& CIK cells SHR-1210,200mg/d,intravenous infusion,d1; CIK cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W. |
| Arm 2: Control | Active comparator | Biological: SHR-1210SHR-1210,200mg/d,intravenous infusion,d1; Q3W. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1210Also: PD-1 inhibitorSHR-1210 injection | Biological | Arm 1: CIK+PD-1i, Arm 2: Control |
| CIK cellsAlso: Cytokine-induced killer cellsCIK cells injection | Biological | Arm 1: CIK+PD-1i |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 41654611Li S, Qin J, Sun Q, Zhao H, Xiong Y, Wang Y, Han Y, Zhang J, Zhang W, Shen M, Yang F, Ren B, Zhou L, Li R, Hui Z, Tian X, Cao S, Du W, Yu W, Liu L, Zhang X, Ren X. Randomized pilot study of camrelizumab with or without autologous cytokine-induced killer cells in refractory clear cell renal cell carcinoma. Sci Rep. 2026 Feb 7;16(1):7768. doi: 10.1038/s41598-026-38881-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiubao Ren, MD. PhD. study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1210 and CIK cells in people with Renal Cell Carcinoma and Clear Cell Renal Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiubao Ren, MD. PhD. (86-22-23340123 ext. 3173, liangcoh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03987698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.