NCT07153952

RT for Adenocarcinoma/Adenosquamous Carcinoma

Evaluation of the Treatment Response and Prognosis of Cervical Adenocarcinoma/Adenosquamous Carcinoma After Radiotherapy Based on Pathologic Characteristics and Multimodal Imaging: a Prospective, Multicenter Trial

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to establish a prospective cohort of locally advanced cervical adenocarcinoma to provide a better way to monitor its efficacy and provide precise treatment. The key problems to be solved are as follows: 1. Establish an observational prospective cohort of locally advanced ADC and randomly divide patients with residual cervical tumors in the primary site after CCRT into the local treatment group (salvage surgery or supplementary radiotherapy) or the systemic treatment group. 2. Collect cervical biopsy tissues before and after CCRT in patients with residual cervical tumors, explore the genomic characteristics, and predict whether they can benefit from targeted/immunotherapy in the future.

Conditions

• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Radiotherapy

Interventions

Type	Name	Description
RADIATION	radiotherapy	The surgical method is determined by the gynecological oncologist, including total hysterectomy, pelvic exenteration, or radical total hysterectomy. The specific surgical choice needs to be comprehensively judged based on the patient's residual tumor location, size, and other complications. Supplementary radiotherapy is mainly image-guided brachytherapy ± external irradiation. The irradiation range and dose must be comprehensively considered based on the location and size of the residual lesions. The best local treatment plan is jointly determined by gynecological oncologists and radiotherapists.
DRUG	Systemic treatment	Systemic treatment regimens include chemotherapy ± targeted therapy ± immunotherapy. According to the NCCN Guidelines (2024.V2), the first-line chemotherapy regimen for persistent, recurrent, or metastatic cervical cancer is preferably carboplatin/paclitaxel and cisplatin/paclitaxel. The addition of immunotherapy can be determined based on the PD-L1 expression level. The specific chemotherapy regimen will be determined by the gynecological oncologist based on the residual tumor site, the number of lesions, and other complications. In addition, if the patient's pathological results indicate HER2 positivity or the genetic test results show PIK3CA mutation, targeted therapy, such as neratinib or apelisimab, can be considered as a second-line regimen after the first-line chemotherapy regimen progresses.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: China