Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorShandong Cancer Hospital and Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A written informed consent form must be signed before the implementation of any trial-related procedures.
Female, aged 18 years or older and 80 years or younger.
ECOG PS 0-1.
Newly diagnosed with histologically or cytologically confirmed primary endometrioid adenocarcinoma, serous carcinoma, clear cell adenocarcinoma, undifferentiated carcinoma, mixed cell adenocarcinoma, mesonephric adenocarcinoma, mucinous carcinoma, intestinal-type mesonephric-like adenocarcinoma, and carcinosarcoma, meeting the clinical diagnostic criteria for endometrial cancer.
Disqualifiers
Subjects with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has completely resolved and does not require any intervention in adulthood may be included; subjects with asthma requiring medical intervention with bronchodilators are not eligible).
Subjects currently using immunosuppressive agents or systemic, or absorbable local corticosteroid therapy to achieve immunosuppressive purposes (dose >10 mg/day prednisone or equivalent) and continuing use within 2 weeks prior to enrollment.
Known history of grade 3 or 4 immune-related adverse events associated with previous anti-tumor immunotherapy.
Poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past six months; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc >450 ms (males); QTc >470 ms (females).
Trial design
Design model
Single group
Treatments tested in this trial
Paclitaxel and Cisplatin
DrugPaclitaxel 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.
Cadonilimab
DrugCadonilimab: 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.
Radiotherapy
RadiationSite 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival
Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first.
Time frame
Progression-Free Survival (PFS) will be assessed from the date of enrollment until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 60 monthsSecondary outcomes
1
Objective Response Rate
ORR refers to the proportion of patients whose optimal response is complete or partial response
Time frame
ORR refers to the proportion of patients whose optimal response is complete or partial response, through study completion, an average of 2 years2
Overall Survival
The time interval from enrollment to death from any cause
Time frame
The time interval from enrollment to death from any cause, assessed up to 60 months3
Disease Control Rate
DCR refers to the proportion of patients whose optimal response is complete or partial response, or stable disease
Time frame
DCR refers to the proportion of patients whose optimal response is complete or partial response, or stable disease, through study completion, an average of 2 years4
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with adverse events and severe as assessed by CTCAE v5.0
Time frame
Data will be recorded before each chemotherapy cycle, before and after radiotherapy, and every 3 months during the follow-up period, an average of 2 yearsOther outcomes
1
Biomarker
CD8A, PD-1, PD-L1, CD68, panCK, CD56, CD155, TIGIT, TMB, MSI, STING, et al
Time frame
Biomarkers will be recorded before each chemotherapy cycle, before and after radiotherapy, and every 3 months during the follow-up period, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov