Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of cadonilimab in combination with paclitaxel, cisplatin, and radiation therapy for the treatment of locally recurrent and oligometastatic endometrial carcinoma. The main questions it aims to answer are:

1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?
2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?

Participants will:

* Receive cadonilimab, paclitaxel, cisplatin, and radiation therapy according to a specified protocol.
* Visit the clinic for regular checkups and tests throughout the treatment period.
* Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.
* Provide hematologic and tissue samples to explore biomarkers.

This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic endometrial carcinoma, as well as identify biomarkers to better guide treatment strategies.

Conditions

• Endometrial Neoplasms
• Neoplasm Recurrence, Local
• Neoplasm Metastasis

Interventions

DRUG

Paclitaxel and Cisplatin

Paclitaxel and Cisplatin Paclitaxel: 135 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W). Cisplatin: 75 mg/m², intravenous infusion, Days 1-3, every 3 weeks (Q3W). Duration: 6-8 cycles, until disease progression or intolerable adverse effects as judged by the investigator. Alternative: If contraindicated for cisplatin, or if there is an allergy to paclitaxel and/or cisplatin, alternative drugs such as different types of paclitaxel or carboplatin can be used.

DRUG

Cadonilimab

Cadonilimab: 5-10 mg/kg, intravenous infusion, Day 1, every 3 weeks (Q3W). Duration: Continuous administration until disease progression, death, intolerable toxicity, subject's voluntary withdrawal, investigator's decision for withdrawal, or a maximum of 24 months.

RADIATION

Radiotherapy

Site Selection: Original site, lymph nodes, lung metastasis, bone metastasis, adrenal metastasis, brain metastasis, and other relatively isolated, well-vascularized lesions. Select at least one suitable lesion for radiotherapy based on the impact of the recurrent or metastatic lesion on the body, prioritizing lesions that cause symptoms, are life-threatening, or are expected to cause symptoms.All tumor lesions will be irradiated, which can be done in phases. Dosage and Fractionation: Conventional or hypofractionated radiotherapy, with a biologically effective dose (BED) of ≥ 72 Gy. Dose adjustments can be made for brain metastases. Timing: After completing relevant baseline examinations, radiotherapy can be implemented generally after 2-6 cycles of systemic therapy, or after the first cycle for small, solitary metastatic lesions. echnique: IMRT, TOMO, SBRT, 3D-BT, interstitial implantation therapy, or proton therapy.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute

  lead OTHER

Principal Investigators

• Peng Xie · Shandong Cancer Hospital and Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-13

Primary Completion

2026-08-31

Completion

2026-09-30

Countries

• China

Study Locations