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| Name | Class |
|---|---|
| Cancer Hospital of The University of Chinese Academy of Sciences | UNKNOWN |
| Cancer Center of the First Affiliated Hospital of Soochow University | UNKNOWN |
| The First Affiliated Hospital of Nanchang University |
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This study is a single arm, phase II multicenter clinical trial to evaluate the efficacy and safety of the combination therapy of Iparomlimab and Tuvonralimab(QL1706) and chemotherapy ± bevacizumab induction therapy followed by concurrent chemoradiotherapy in patients with locally advanced cervical cancer at high risk of IVA stage and/or giant cervical tumors and/or giant metastatic lymph nodes and/or multiple metastatic lymph nodes.
The enrolled patients first receive 2 cycles of combined drug induction therapy: paclitaxel+cisplatin/carboplatin ± bevacizumab+QL1706, every 3 weeks for 2 cycles; After induction therapy, synchronous radiotherapy and chemotherapy combined with immunotherapy: extracorporeal irradiation+post loading radiotherapy+synchronous chemotherapy+immunotherapy. During radiotherapy, single agent cisplatin/carboplatin treatment for 5 courses per week+QL1706 treatment every 3 weeks for 3 courses; After the end of radiotherapy and chemotherapy, immune maintenance therapy will be administered for six months: treatment with QL1706 every 3 weeks for 9 courses, followed by a follow-up period until the end of radiotherapy for 2 years or death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 cycles of combined drug induction therapy: every 3 weeks for 2 cycles; After ,synchronous radiotherapy and chemotherapy combined immunotherapy | Combination Product | The enrolled patients first receive 2 cycles of combined drug induction therapy: paclitaxel+cisplatin/carboplatin ± bevacizumab+QL1706, every 3 weeks for 2 cycles; After induction therapy, synchronous radiotherapy and chemotherapy combined with immunotherapy: extracorporeal irradiation+post loading radiotherapy+synchronous chemotherapy+immunotherapy. During radiotherapy, single agent cisplatin/carboplatin treatment for 5 courses per week+QL1706 treatment every 3 weeks for 3 courses; After the end of radiotherapy and chemotherapy, immune maintenance therapy will be administered for six months: treatment with QL1706 every 3 weeks for 9 courses, followed by a follow-up period until the end of radiotherapy for 2 years or death. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year PFS | 2-year PFS rate evaluated by researchers based on RECIST v1.1 and biopsy pathology | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | ORR of drug-induced therapy evaluated by researchers based on RECIST v1.1 and biopsy pathology | 2 year |
| DCR | DCR of drug-induced therapy evaluated by researchers based on RECIST v1.1 and biopsy pathology |
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Inclusion Criteria:
1. Sign a written informed consent before any trial-related procedures. 2. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma.
3. Patients with stage Ⅳa confirmed by endoscopic biopsy and/or stage IB3-IIIC (FIGO 2018 staging) with large cervical tumors (maximum diameter ≥ 6 cm) and/or large lymph nodes (maximum short diameter of cross-section ≥ 2 cm) and/or ≥ 3 lymph node metastases confirmed by CT/MR/PET.
4. Female patients aged ≥ 18 years and ≤ 75 years. 5. KPS ≥ 70. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
7. Expected survival of more than 6 months. 8. No previous radiotherapy, chemotherapy, immunotherapy or targeted therapy. 9. Major organ functions meet the following requirements: Absolute neutrophil count ≥ 1.5×109/L, platelet count ≥ 80×109/L, hemoglobin ≥ 80g/L; Total bilirubin level ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min; Serum albumin ≥ 28g/L; thyroid stimulating hormone (TSH) ≤ 1×ULN (if abnormal, FT3 and FT4 levels should also be examined. If FT3 and FT4 levels are normal, the subject can be enrolled).
10. Subjects agree to use effective contraceptive measures from the time of signing the informed consent until 180 days after the last dose. Women of childbearing age must not be pregnant or lactating.
11. All subjects must be willing to provide tumor tissue samples, blood samples, urine samples, fecal samples, and vaginal secretion samples after enrollment.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanmei Lou, chief physician | Contact | 086-13666698395 | zjszlyy@zjcc.org.cn |
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| Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University | OTHER |
| People's Hospital of Quzhou | OTHER |
| First Affiliated Hospital of Ningbo University | NETWORK |
| Wenzhou Central Hospital | OTHER |
| Jinhua Municipal Central Hospital | OTHER |
| First Hospital of Zhejiang University | UNKNOWN |
| First Affiliated Hospital of Zhejiang University | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
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|
| 2 year |
| OS | 2-year OS | 2 year |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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