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

Sun Yat-sen University

Status and phase

Not yet enrolling

Phase 2

Conditions

Non Clear Cell Renal Carcinoma

Treatments

Drug: Anlotinib plus Sintilimab

Study type

Interventional

Funder types

Other

Identifiers

NCT05220267

SL-B2021-245-02

Details and patient eligibility

About

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.

Enrollment

43 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.