Cervical Cancer
Conditions
Interventions
Intervention Group: Induction chemotherapy with toripalimab in combination with the TP or TC regimen
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Biopsy-confirmed HPV-positive invasive cervical carcinoma, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. (2) Cervical cancer with high-risk lymph node metastasis confirmed through standard diagnostic procedures. (3) Medical history review and gynecological examination must be performed within 14 days prior to enrollment to confirm tumor size and FIGO staging. (4) Within 30 days before enrollment, one of the following imaging studies must have been performed: non-contrast chest CT, contrast-enhanced abdominal CT, MRI, or PET/CT. Additionally, lymph node ultrasound must confirm the location, size, and number of metastatic lymph nodes. (5) Performance status score of 0 or 1. (6) Age between 18 and 65 years. (7) Laboratory tests must be completed within 14 days prior to enrollment to assess bone marrow, liver, and renal function: WBC >= 3.5 × 10?/L (normal range) Neutrophils >= 1.5 × 10?/L Platelets >= 100 × 10?/L Hemoglobin >= 90 g/L (transfusion or other corrective measures are acceptable) Normal liver function: ALT and AST 60 mL/min; Calculation formula: CCr = (140 - age) × weight (kg) / [72 × Scr (mg/dL)] or: CCr = [(140 - age) × weight (kg)] / [0.818 × Scr (µmol/L)]; International normalized ratio (INR) <= 1.5 (8) Women of childbearing potential must agree to use effective contraception throughout the entire treatment and study period. (9) Patients must provide written informed consent before enrollment.
Exclusion criteria
Exclusion criteria: (1) Undifferentiated carcinoma, small cell carcinoma, neuroendocrine carcinoma, or sarcoma of the cervix. (2) History of prior invasive malignancy, except for non-melanoma skin cancer. (3) Receipt of systemic chemotherapy within the past 3 years. (4) Previous history of radiotherapy to the pelvis or abdomen. (5) Presence of distant metastases to other organs. (6) Severe active comorbid conditions including: a. Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months; b. Transmural myocardial infarction within the last 6 months; c. Acute bacterial or fungal infection requiring intravenous antibiotic therapy at the time of registration; d. Chronic obstructive pulmonary disease exacerbation or other pulmonary illness requiring hospitalization or interfering with study participation; e. Hepatic impairment leading to jaundice or coagulopathy; f. Acquired immunodeficiency syndrome (patients diagnosed with AIDS, or those suspected of having AIDS who refuse HIV testing); g. Other immunocompromised states (e.g., organ transplantation, long-term corticosteroid use). (7) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, PFS;Mode of Treatment Failure;Quality of Life (QoL) Assessment ; | — |
Countries
China
Contacts
Public ContactWu Xingrao
Yunnan Cancer Hospital
Outcome results
None listed