A Study of Sintilimab in Combination With Axitinib in Advanced Renal Cell Cancer (SAARCC)

Tianjin Medical University Second Hospital

Status and phase

Not yet enrolling

Phase 2

Conditions

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Treatments

Drug: Sintilimab

Drug: Axitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT04958473

SAARCC

Details and patient eligibility

About

In patients with recurrent or metastatic renal cell carcinoma, a preliminary evaluation of the safety and efficacy of sintilimab combined with axitinib in patients with advanced renal cell carcinoma was conducted.Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and disease remission rate (ORR) were evaluated.

Full description

Patients with recurrent or metastatic renal cell carcinoma received axitinib tablets (5mg bid po) combined with sintilimab (200mg d1) on a 3-week (21-day) as a one-cycle regimen.6 months of continuous administration (i.e., 8 cycles of sintilimab) or until tumor progression or unacceptable toxicity or death or subject withdraws informed consent;If the drug has been discontinued or the tumor has progressed, and there are no intolerable side effects, the drug can be continued according to the judgment of the researchers and the will of the subjects. Drug safety was evaluated before each cycle.The first efficacy was evaluated after 2 cycles.The efficacy was then evaluated every 2 cycles.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed written informed consent before performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
Diagnosis of locally advanced or metastatic RCC that is predominantly clear cell histology
Must have measurable disease
Subject has received no prior systemic therapy
A woman is eligible to participate in the study if she is of Non-childbearing potential, has a negative serum pregnancy test within 7 days of the first dose of study treatment, not lactating, and agrees to use adequate contraception during the study until at least 120 days after the last dose of investigational product
Eastern Cooperative Oncology Group performance status 0 or 1
Adequate organ function as defined in the protocol
Left ventricular ejection fraction >= lower limit of normal as assessed by echocardiogram or multigated acquisition scan

Exclusion criteria

Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Subject is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study treatment
Subject is expected to require any other form of systemic or localized antineoplastic therapy while on study
Subject is on any systemic steroid therapy, within one week before the planned date for first dose of study treatment. Subject is on any other form of immunosuppressive medication
Unable to swallow and retain orally administered medication
Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other -Gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, GI perforation, or intra-abdominal abscess within 4 weeks before beginning study treatment
Known history of HIV infection or a known history of or is positive for Hepatitis B or Hepatitis C
Presence of active infection requiring systemic therapy
Corrected QT interval duration prolongation
History of any one or more of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; ----History of Class III or IV congestive heart failure according to New York Heart Association classification
History of cerebrovascular accident within the past 6 months
Poorly controlled hypertension
History of untreated deep venous thrombosis
Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
Has taken any prohibited medications that are listed in the protocol within 14 days of the first dose of study treatment. Subject has received or will receive a live vaccine within 30 days before the first administration of study treatment