Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Axitinib

Immunoglobulins

Protein Kinase Inhibitors

Enzyme Inhibitors

Neoadjuvant group will be given the neoadjuvant combination of axitinib plus Toripalimab + nephrectomy

The control group will be given nephrectomy alone.

Preoperative treatment with axitinib will be given for 3 months, 5 mg twice daily, orally. Preoperative treatment with Toripalimab will be given for 4 cycles (3 weeks considered one cycle), 240 mg, Q3W.

Axitinib plus Toripalimab

nephrectomy

Zhiling Zhang, Professor

Sujun Han, Dr

Zhisong He, Dr

Zhiling Zhang, Dr

JUn Xiao, Dr

Hailiang Zhang, Dr

Hao Zeng, Dr

Yao Xin, Dr

Xuepei Zhang, Dr

Fangjian Zhou, Professor

The study included 246 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1.

Given the good results of TKI plus PD-1 in our previous cases and its good effect on advanced RCC, we plan to eliminate tumor micrometastases and improve anti-tumor immunity with the neoadjuvant combination of axitinib plus PD-1, so as to improve patient outcomes. The study included 246 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1 and provide evidence-based medical evidence for clinical perioperative treatment of these patients.

Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

A Multicenter Randomized Controlled Clinical Study of Neoadjuvant Combination of Axitinib Plus PD-1 Monoclonal Antibody to Improve Disease Free Survival of Patients With Renal Cell Carcinoma

To evaluate the efficacy of the neoadjuvant combination of axitinib plus PD-1 in improving the 2-year disease-free survival (DFS) in RCC patients with high-risk for recurrent (T2G3-4 or T3-4, or N1). Disease-free survival (DFS) is defined as time from registration to disease progression or death.

cancer specific survival (CSS) is defined as the period between the date of randomization and the date of death from renal cancer.

overall survival (OS) is defined as the period between the date of randomization and the date of death from any cause

MPR (≤10% viable malignant cells per local pathology assessment)

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Pfizer

ZHOU FANGJIAN

Professor

Digestive System Diseases

Biliary Tract Neoplasms

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Biliary Tract Diseases

Angiogenesis Inhibitors

Endothelial Growth Factors

Mitogens

Axitinib (Inlyta, Pfizer Inc.) is a novel oral angiogenesis inhibitor that selectively targets vascular endothelial growth factor (VEGFR) 1, 2 and 3.

Toripalimab (Shanghai Junshi Biosciences Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.

Axitinib 5mg, twice a day, orally, 4 weeks a cycle. Dose reduction from 5mg twice a day to 3mg twice a day should be considered according to adverse events.

Toripalimab 240mg, every 3 weeks, intravenous infused, 6 weeks a cycle. Number of cycle: until disease progression or unacceptable toxicity events.

axitinib plus toripalimab

Xiaobo Yang, MD

Haitao Haitao, Prof

Xiao-Bo Yang, MD

Hai-Tao Zhao, MD

The investigators design a phase II clinical study to explore the efficacy and safety of axitinib plus toripalimab as a second-line treatment in patients with hepatobiliary malignant tumors and to analyze potential biomarkers of therapeutic response.

This phase II trial is a single-arm, non-randomized and single-center clinical study.

It is estimated that 60 patients who met the study criteria will be enrolled in PUMCH and treated with axitinib plus toripalimab. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment, including overall survival and time to progression, until disease progression or death. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response.

Study Type: Interventional. Masking: Open Label.

Patients were confirmed with advanced hepatobiliary malignancies by imaging and histological examination and meet with the inclusive criteria, including hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, gallbladder carcinoma, and mixed cancer).

Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors

Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors: a Single-arm, Non-randomized, Single-center Phase II Trial

Tumor mutation burden assessed by whole exome sequencing.

Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.

A duration from the date of initial treatment with axitinib plus toripalimab to disease progression (defined by RECIST 1.1) or death of any cause.

Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

Duration from the date of initial treatment with axitinib plus toripalimab to the date of death due to any cause.

Duration from the first time reported partial response or complete response to the first time of disease progression or death.

Proportion of patients with stable disease status more than 4 months.

Portion of patients who do not experience disease progression (defined by RECIST 1.1) or death of any cause after treated with axitinib plus toripalimab for 3 months and 6 months, respectively.

Portion of patients who die of any cause after treated with axitinib plus toripalimab for 6 months and 12 months, respectively.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma	NCT05738694	Renal Cell Carc... Neoadjuvant	Axitinib plus T... nephrectomy	18 Years - 80 Years	Sun Yat-sen University
Axitinib Plus Toripalimab as Second-line Treatment in Hepatobiliary Malignant Tumors	NCT04010071	Hepatobiliary N... Liver Neoplasm Biliary Tract N...	axitinib plus t...	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for axitinib plus toripalimab