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Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma

Sponsor
Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05220267
Collaborator
(none)
43
Enrollment
1
Location
1
Arm
34
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant anti-tumor activity in certain cancer. The goal of this study was to evaluate the efficacy and safety of sintilimab (a human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor, inhibiting tumor angiogenesis and proliferative signaling) in advanced non clear cell renal cell carcinoma.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anlotinib plus Sintilimab
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma
Anticipated Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Anlotinib plus Sintilimab

Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle) .Sintilimab was administered intravenously (200mg once every 3weeks).

Drug: Anlotinib plus Sintilimab
Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle).Sintilimab was administered intravenously (200mg once every 3weeks).

Outcome Measures

Primary Outcome Measures

  1. progression-free survival (PFS) [up to 2 years]

    Time from treatment until disease progression or death

Secondary Outcome Measures

  1. objective response rate (ORR) [up to 2 years]

    objective response rate (ORR) by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR)

  2. disease control rate (DCR) [up to 2 years]

    disease control rate (DCR)by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR) and Stable Disease(SD).

  3. overall survival (OS) [up to 2 years]

    Time from treatment until death from any cause

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Subjects voluntarily joined the study and signed informed consent;

  • Aged > 18 years;

  • ECOG body status score is 0 or 1,Expected survival time is greater than 3 months.

  • Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.

  • Patients must have measurable lesions as defined by the RECIST 1.1 standard;

  • Adequate hematologic and end-organ function as defined by the following laboratory results obtained within 28 days prior to the first study treatment:

  1. Absolute neutrophil count (ANC) ≥1.5x 109/L

  2. Lymphocyte count ≥ 500/uL.

  3. Platelet count ≥ 80x109/L.

  4. Hemoglobin ≥ 80 g/L (patients may be transfused to meet this criterion).

  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) with the following exceptions: Patients with documented liver/bone metastases should have AST and ALT ≤ 5 x ULN.

  6. Serum bilirubin ≤ 1.5 x ULN.

  7. Creatinine clearance ≥ 60 mL/min.

  8. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective forms of contraception and to continue its use 4 weeks after the last dose of anlotinib or sintilimab.

  • Signed informed consent form.

  • Ability and capacity to comply with study and follow-up procedures.

Exclusion Criteria:

  • Those who are known to be allergic to pharmaceutical ingredients.

  • Receive anti-tumor monoclonal antibody or other research drugs within 4 weeks before enrollment; have received other anti-PD-1 antibody therapy or other treatment for PD-1/PD-L1;

  • Previous use of anlotinib or other angiogenesis inhibitors

  • The patient has any active autoimmune disease or a history of autoimmune disease;

  • There are uncontrolled heart clinical symptoms or diseases;

  • Patients with congenital or acquired immune deficiency;

  • Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment;

  • A history of gastrointestinal perforation or major surgery within 4 weeks before enrollment;

  • Overactive/venous thrombosis occurred within 6 months prior to enrollment, such as cardiovascular-cerebral vascular (including transient ischemic attack),deep vein thrombosis (except for patients who have recovered from venous catheterization due to previous chemotherapy)and pulmonary embolism;

  • Those with active bleeding or bleeding tendency;

  • Presence of a drug uncontrolled hypertension;

  • Urine routine indicates more than urinary protein 2+;

  • Correct QT interval > 470msec; if the patient has a prolonged QT interval, but the investigator's study evaluates that the prolongation is due to a cardiac pacemaker (and no other abnormalities in the heart), it is necessary to discuss with the sponsor's researcher to determine if the patient is Suitable for group study;

  • Patients suspected of having other primary cancers;

  • Those who are known to be allergic to pharmaceutical ingredients.

  • Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening). Patients with past/resolved HBV infection (defined as having negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. A negative HBA DNA test must be obtained in patients with positive hepatitis B core antibody prior to Cycle 1 Day 1.

  • Active hepatitis C infection. Patients positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA.

  • Pregnant or lactating women.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer Center, Sun Yat-sen University Guangzhou Guangdong China 510060

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ZHOU FANGJIAN, Director, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05220267
Other Study ID Numbers:
  • SL-B2021-245-02
First Posted:
Feb 2, 2022
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms

Study Results

No Results Posted as of Feb 2, 2022