Locally Advanced Cervical Cancer
Conditions
Interventions
Test group:SHR-1316 plus concurrent chemoradiotherapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participated in this study, signed the informed consent form, exhibited good compliance, and were able to cooperate with follow-up visits; 2. Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix; 3.Clinical stage IIIC2-IVA (FIGO 2018 staging): Lymph node involvement is assessed based on one of the following criteria: - Histologically confirmed lymph node involvement through biopsy; - MRI or CT showing one or more positive para-aortic lymph nodes with a minimum diameter of >=15mm; - PET/CT showing one or more positive para-aortic lymph nodes with an SUVmax of >=2.5. 4. At least one measurable lesion that meets the RECIST v1.1 criteria (according to RECIST v1.1, the measurable lesion should have a long diameter of =10 mm on spiral CT scan or a short diameter of >=15 mm for enlarged lymph nodes); 5. Investigator assess it is suitable for concurrent chemoradiotherapy; 6. Capable of providing tumor tissue specimens (tissue blocks fixed in formalin and embedded in paraffin (FFPE) or unstained FFPE slides), or capable of cooperating with biopsy during the screening period to provide fresh tumor tissue; 7. Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8. BMI>=18.5kg/m^2; 9. Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of drug,Female participants' HCG must be negative within 3 days prior to enrollment and must be non-lactating. 10. Female, aged 18 to 75 years old (inclusive of 18 and 75 years old, calculated as of the date of signing the informed consent form); 11. Expected survival time > 3 months; 12. Functions of Major Organs and Bone Marrow Must Meet the Following Requirements: Complete Blood Count (CBC) Tests: (No blood transfusion, no corrective treatment with cytokine drugs such as G-CSF within 14 days before enrollment); Hemoglobin (HB) >= 90 g/L; Absolute Neutrophil Count (ANC) >= 1.5×10?/L; Platelet Count (PLT) >= 100×10?/L; White Blood Cell Count (WBC) >= 3.0×10?/L and = 30 g/L; Creatinine (Cr) = 45 mL/min (calculated by the Cockcroft-Gault formula, see Appendix 1 for details); Thyroid-Stimulating Hormone (TSH) = 50%.
Exclusion criteria
Exclusion criteria: 1. Histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix; 2. Pathological or imaging examination confirms the presence of distant metastatic disease, including lymph nodes located above the first lumbar vertebra (L1) (cephalic side) or in the inguinal region (with a short diameter of >=15mm); 3. has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy; 4. In the investigator's judgment, there is a disease (such as severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, confuses the study results, or interferes with the subject's ability to complete the study. 5. Subjects with a history of or current vesical fistula, vaginal fistula, or rectal fistula; or those with imaging evidence of tumor invasion into the bladder or rectum, and assessed by the investigator as having a risk of perforation. 6. Subjects with a history of receiving or currently receiving any of the following treatments: Anti-tumor treatments for cervical cancer, including surgical treatment (except for biopsy, puncture surgery, or palliative local surgery performed >= 1 week before enrollment), chemotherapy, radiotherapy, and molecular targeted therapy (including other oral targeted drugs used in clinical trials); Immunotherapy, including but not limited to other anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, bispecific antibodies, or therapeutic anti-cancer vaccines; Administration of live vaccines within 4 weeks before enrollment or planned to be administered during the study treatment period; Receipt of immunosuppressant treatment within 4 weeks before enrollment, except for local steroid treatment, systemic corticosteroid treatment with a dose not exceeding 10 mg/day of prednisone or its physiologically equivalent dose, and treatment as a preventive medication for allergic reactions; 7. Subjects receiving thrombolytic/anticoagulant therapy. Prophylactic use of low-dose aspirin (<= 100 mg/day) and low-molecular-weight heparin (<= 40 mg/day) is permitted. Key Notes on Translation:; 8. Subjects with a history of (within 5 years) or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin and carcinoma in situ. 9. Subjects with any active or known autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.). The following subjects are permitted to enroll: those with Type 1 diabetes mellitus receiving stable-dose insulin therapy; those with hypothyroidism requiring only hormone replacement therapy; those with Hashimoto's thyroiditis that does not require treatment; and those with skin diseases (e.g., eczema, vitiligo, or psoriasis) that do not require systemic treatment and have had no acute exacerbation within 1 year before the screening period. 10. Subjects with a history of (non-infectious) pulmonary inflammation/interstitial lung disease (ILD) requiring steroid treatment, or currently suffering from (non-infectious) pulmonary inflammation/ILD that requires steroid treatment. 11. Subjects with severe infection (e.g., requiring intravenous administration of antibiotics, antifungals, or antiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, incidence and grade of drug-related adverse events of grade 3 and above;Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR);Overall Survival (OS);Progression free survival (PFS);2-year progression-free survival rate (2-year PFS rate);3-year overall survival rate (3-year OS rate); | — |
Countries
China
Contacts
Public ContactXiaohua Wu
Fudan University Shanghai Cancer Center
Outcome results
None listed