Envafolimab Combined With Axitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Summary

Introduction:

This document explains a clinical research study conducted at Peking Union Medical College Hospital. The study aims to evaluate a new combination treatment - Envafolimab (an immunotherapy) and Axitinib (a targeted therapy) - for patients newly diagnosed with advanced kidney cancer (specifically, clear cell Renal Cell Carcinoma or RCC). This information is designed to help patients, their families, and healthcare providers understand the study's purpose, procedures, potential benefits and risks, and what participation involves.

1. What is the Study About?

* The Problem: Advanced kidney cancer (RCC) that has spread (metastatic) or cannot be removed by surgery (unresectable) is challenging to treat. While treatments exist, researchers are always looking for more effective and manageable options, especially for patients who haven't had prior systemic (whole-body) anti-cancer therapy.
* The New Approach: This study combines two types of drugs:

* Envafolimab: An "immunotherapy" drug given as an injection under the skin (subcutaneous). It works by blocking a protein called PD-L1 on cancer cells or immune cells. Blocking PD-L1 helps the patient's own immune system recognize and attack the cancer cells more effectively.
* Axitinib: A "targeted therapy" drug taken as a pill twice daily. It works by blocking signals (VEGF receptors) that cancer cells use to grow new blood vessels, essentially starving the tumor of its blood supply.
* The Goal: To find out if giving Envafolimab and Axitinib together is safe and effective as the first treatment for patients with advanced kidney cancer. Researchers want to see how well the combination shrinks tumors, controls the cancer, and how long patients live without their cancer getting worse, while carefully monitoring side effects.
* Study Design:

* Phase II: This is an early stage of testing in patients, focusing mainly on how well the treatment works and its safety profile in a specific group.
* Single-Arm: All participants in this study will receive the same combination treatment (Envafolimab + Axitinib). There is no separate group receiving a different treatment or placebo for comparison in this particular study.
* Single-Center: Currently being run at Peking Union Medical College Hospital (but could potentially expand).
* Participants: Plans to enroll about 30 patients.
* Treatment Duration: Patients receive treatment as long as it's working (tumor isn't growing) and they can tolerate the side effects, for up to a maximum of 2 years.
2. Key Information for Patients \& Families:

* Who Might Qualify? You may be eligible to participate if you:

* Are between 18 and 75 years old.
* Have been diagnosed with advanced clear cell kidney cancer (unresectable or metastatic).
* Have NOT received any prior systemic anti-cancer treatment (like chemotherapy, immunotherapy, or other targeted therapies) for your advanced kidney cancer.
* Have tumors that can be measured on scans (CT or MRI).
* Are relatively active and able to care for yourself (ECOG performance status 0 or 1: meaning you are either fully active or restricted in physically strenuous activity but ambulatory and able to do light work).
* Have adequate organ function (healthy enough bone marrow, liver, kidneys, heart) as determined by blood tests.
* Are expected to live at least 6 more months.
* Understand the study and agree to follow the procedures and attend all visits.
* Who Would Not Qualify? You would likely not be eligible if you:

* Have another active cancer besides the kidney cancer being studied.
* Have had previous systemic treatment for your advanced kidney cancer.
* Have known severe allergies to similar drugs or components of Envafolimab/Axitinib.
* Have an active autoimmune disease needing strong medication (like high-dose steroids or immunosuppressants) within the last 2 years. (Hormone replacements like thyroid meds are okay).
* Are taking high-dose steroids (except inhaled/nasal) or other immune-suppressing drugs shortly before starting.
* Are using traditional Chinese medicine or immunomodulators within 2 weeks before joining.
* Have serious uncontrolled heart problems (like recent heart attack, severe heart failure, unstable angina, significant irregular heartbeats).
* Have uncontrolled fluid build-up needing drainage (like large amounts of ascites or pleural effusion).
* Are pregnant, breastfeeding, or unwilling to use highly effective contraception during the study and for 6 months after.
* Have significant psychiatric, substance abuse, or other medical/social issues that the research team believes would interfere with the study.

Conditions

• Advanced Renal Cell Carcinoma (aRCC)

Interventions

DRUG

Envafolimab Injection, Axitinib Tablets

Envafolimab + Axitinib * Envafolimab 400 mg, subcutaneous injection, day 1, every 3 weeks; * Axitinib 5 mg, orally, twice daily

Sponsors & Collaborators

• Peking Union Medical College Hospital

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-02-20

Completion

2027-07-20