Cervical cancer
Conditions
Interventions
Treatment:Exemption from brachytherapy
Sponsors
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed squamous cell carcinoma of the cervix; 2.Age >= 18 years; 3.Newly diagnosed with stage IB1-IVA (FIGO 2018); 4.Maximum diameter of cervical tumor <= 6 cm; 5.ECOG performance status of 0-1; 6.After induction treatment with QL-1706 combined with albumin-bound paclitaxel and cisplatin (<= 3 cycles) in the LACCIB-01 study, cervical lesions must achieve clinical complete remission (complete tumor disappearance must be confirmed by at least three methods: (1) Imaging, with enhanced MRI as the preferred method, followed by enhanced CT or PET-CT; (2) Gynecological examination; (3) At least two biopsy samples taken from different sites under colposcopy. Note: No requirement for complete remission of metastatic lymph nodes.); 7.Major organ functions meet the protocol criteria within 7 days prior to treatment; 8.Signed the informed consent form and agreed to participate in the study.
Exclusion criteria
Exclusion criteria: 1.Patients with other histological types of cervical cancer, such as adenocarcinoma, adenosquamous carcinoma, neuroendocrine carcinoma, sarcoma, etc. 2.No induction treatment or failure to achieve complete remission of cervical lesions after induction treatment; 3.Evidence of distant metastasis, including inguinal lymph node metastasis and lymph node metastasis above the the first lumbar vertebra on the cranial side. 4.History of total hysterectomy (removal of the uterine body and cervix). Patients with a history of subtotal hysterectomy or procedures preserving the cervix (e.g., cornual resection) are permitted. Patients with positive intra-abdominal lymph nodes >4 cm who underwent lymphadenectomy are also permitted. 5.Anatomical abnormalities or tumor-related contraindications that prevent the use of brachytherapy. 6.History of other active malignant tumors within the past 2 years, except for those types of tumors that are locally curable and have been cured, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, or breast carcinoma in situ. 7.Presence of clinically significant bilateral hydronephrosis that, in the investigator’s judgment, cannot be relieved by nephrostomy or ureteral stent placement. 8.Active hepatitis B infection, subjects with non-active or asymptomatic hepatitis B virus (HBV) carriers (HBsAg positive) and HBV DNA > 1000 IU/mL, and subjects with active hepatitis C infection. 9.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 10.Pregnant or breastfeeding women; 11.Any of the following cardiovascular or cerebrovascular conditions: Heart failure with a NYHA (New York Heart Association) functional classification >= II; Serious arrhythmias requiring long-term medical intervention. Asymptomatic patients with stable atrial fibrillation are allowed. Cerebrovascular event (CVA) within the last 6 months prior to randomization; Left ventricular ejection fraction (LVEF) < 50%. 12.Anatomical abnormalities or tumor-related contraindications that prevent the use of brachytherapy; 13.Major surgery (as determined by the investigator), open biopsy, or significant trauma within 4 weeks prior to enrollment, or planned major surgery during the study period. Systemic pelvic/para-aortic lymph node dissection for diagnostic purposes is allowed;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;Safety; | — |
Countries
China
Contacts
Public ContactBai Shoumin, Lu Huaiwu
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed