RT for Adenocarcinoma/Adenosquamous Carcinoma

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

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Heilongjiang Cancer Hospital

  collaborator UNKNOWN

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Obstetrics and Gynecology Hospital of Zhejiang University

  collaborator UNKNOWN

• Luohe Central Hospital

  collaborator UNKNOWN

• Peking Union Medical College Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2027-01-01

Completion

2028-01-01

Countries

• China

Study Locations