Clinical Trials /

Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma

NCT04387500

Description:

This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in fumarate hydratase-deficient renal cell carcinoma.

Related Conditions:
  • Renal Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma
  • Official Title: Single-arm Phase II Clinical Trial to Evaluate the Initial Efficacy and Safety of Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: 20190813
  • NCT ID: NCT04387500

Conditions

  • Carcinoma, Renal Cell
  • Fumarate Hydratase Deficiency
  • Immunotherapy

Interventions

DrugSynonymsArms
Sintilimab injectionInlytaSintilimab injection combined with Inlyta

Purpose

This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in fumarate hydratase-deficient renal cell carcinoma.

Detailed Description

      Our previous genetic research as well as other published data indicated the possible well
      response to combination of immunotherapy with targeted therapy in FH-deficient renal cell
      carcinoma, therefore we intented to perform this single-arm phase II clinical trial to
      evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in
      FH-deficient renal cell carcinoma.
    

Trial Arms

NameTypeDescriptionInterventions
Sintilimab injection combined with InlytaExperimentalSintilimab injection 10ml: 100mg, 200mg intravenously, once every three weeks. Course of treatment: discontinue medication when the disease progresses clinically or radiologically. Inlyta 5mg orally, twice a day. Course of treatment: continue treatment as long as a clinical benefit is observed, or until an unacceptable toxicity is present that cannot be controlled by combination or dose adjustment. In the whole research process, if the disease progresses, the attending doctor has the right to carefully choose other anti-tumor methods, including radiotherapy, chemotherapy and other targeted drugs.
  • Sintilimab injection

Eligibility Criteria

        Inclusion Criteria:

          1. age ≥ 18;

          2. histology characteristics accord with FH-deficient RCC;

          3. gene testing confirms germline and/or somatic FH gene mutation ;

          4. ECOG (Eastern Cooperative Oncology Group)≤2;

          5. expected survival >3 months;

          6. blood routine indexes: neutrophils ≥1.5*109, platelets ≥100*109, hemoglobin ≥90g/L;

          7. liver function: bilirubin ≤ normal upper limit 1.5 times, AST≤ normal upper limit 2.5
             times;Serum creatinine ≤ 1.5 times of normal upper limit;Serum calcium concentration:
             ≤12.0 mg/dL;

          8. coagulation function: PT≤ 1.5 times of normal upper limit;

          9. the following diseases did not appear within 12 months: myocardial infarction, severe
             or unstable angina pectoris, asymptomatic heart failure, cardiovascular and
             cerebrovascular accident or transient ischemic attack, etc.

         10. all patients signed informed consent.

        Exclusion Criteria:

          1. other malignancies previously or at the same time that are different from the primary
             site or histology of the tumor assessed in this study, except cervical carcinoma in
             situ, basal-cell carcinoma that has been fully treated, superficial bladder tumor (Ta,
             Tis, T1) or other malignancies that occurred before the enrollment and have been cured
             for more than 3 years;

          2. renal decompensation requires hemodialysis or peritoneal dialysis;

          3. arrhythmia need anti-arrhythmic treatment, symptomatic coronary artery disease or
             myocardial ischemia (myocardial infarction), nearly six months, or congestive heart
             failure than NYHA Ⅱ level; Hypertension (systolic blood pressure >160 mmHg or
             diastolic blood pressure >100 mmHg) that has been treated with 2 or more
             antihypertensive treatments and still cannot be controlled;

          4. severe active clinical infection;

          5. patients with coagulation disorder or bleeding constitution;

          6. major surgery or severe trauma was performed within 4 weeks before enrollment;

          7. a history of allogeneic organ transplantation or bone marrow transplantation;

          8. drug abuse and medical, psychological or social conditions that may interfere with
             patients' participation in research or affect the evaluation of results;

          9. known or suspected allergy to the study drug;

         10. those who received treatment other than this study within 4 weeks prior to and during
             the study period.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:PFS
Time Frame:3 years
Safety Issue:
Description:progression-free survival

Secondary Outcome Measures

Measure:OS
Time Frame:3 years
Safety Issue:
Description:overall survival
Measure:life quality
Time Frame:3 years
Safety Issue:
Description:evaluate life quality using EuroQol-5D utility score (EQ-5D index) and the EQ-5D visual analogue scale (EQ-VAS) responses

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:West China Hospital

Trial Keywords

  • Sintilimab
  • Inlyta

Last Updated

May 9, 2020