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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Chemotherapy:TP (Paclitaxel and Cisplatin) Immunotherapy:Cadonilimab Radiotherapy:All tumor lesions will be irradiated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel and Cisplatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | ORR refers to the proportion of patients whose optimal response is complete or partial response | ORR refers to the proportion of patients whose optimal response is complete or partial response, through study completion, an average of 2 years |
| Overall Survival |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker | CD8A, PD-1, PD-L1, CD68, panCK, CD56, CD155, TIGIT, TMB, MSI, STING, et al | 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 years |
Inclusion Criteria:
(1) Hematology standards (without blood transfusion or hematopoietic growth factor treatment within 14 days before enrollment):
a) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, total serum bilirubin ≤1.5×ULN, alkaline phosphatase (ALP) ≤3×ULN, serum albumin ≥30 g/L; b) Serum creatinine (Cr) ≤1.5×ULN; if serum creatinine is >1.5×ULN, creatinine clearance (CrCl) ≥50 mL/min (calculated using the Cockcroft-Gault formula); c) Prothrombin time (PT) prolongation ≤6 seconds, activated partial thromboplastin time (APTT) ≤1.5×ULN; d) Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, FT3 and FT4 levels should be considered; if FT3 and FT4 levels are normal, enrollment is allowed); f) Left ventricular ejection fraction (LVEF) >50%. 11. Before starting the first treatment, all reversible toxic reactions from previous anti-tumor treatments must have resolved to ≤ grade 1 (based on CTCAE v5.0), excluding any grade of alopecia and pigmentation, ≤ grade 2 peripheral sensory neuropathy, and other abnormalities considered by the investigator and/or sponsor to pose a benefit-risk balance favoring the subject receiving the study treatment.
12. Non-surgically sterilized or childbearing potential female patients must use medically recognized contraception (e.g., intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment. Non-surgically sterilized childbearing potential female patients must have a negative serum or urine HCG test within 7 days before enrollment and must not be breastfeeding.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Liu | Contact | +86 13065077425 | 13065077425@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Xie | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital Affiliated to Shandong First Medical University | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D009364 | Neoplasm Recurrence, Local |
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C111043 | TP protocol |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
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| Cadonilimab | Drug | 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. |
|
|
| Radiotherapy | Radiation | 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. |
|
The time interval from enrollment to death from any cause |
| The time interval from enrollment to death from any cause, assessed up to 60 months |
| Disease Control Rate | DCR refers to the proportion of patients whose optimal response is complete or partial response, or stable disease | 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 years |
| 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 | 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 years |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |