A Clinical Study on the Treatment of LACC With Cadonilimab Combined With Chemotherapy Followed by CCRT

A Phase III, Multicenter, Open-label, Randomized Controlled Clinical Study on the Treatment of Locally Advanced Cervical Cancer With Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy

This study mainly evaluated the efficacy and safety of Cadonilimab combined with chemotherapy followed by concurrent chemoradiotherapy versus standard concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer.

Inclusion Criteria:

To be enrolled, subjects had to meet all of the following criteria:

1. Female, aged 18-70 years (inclusive of cutoff values);
2. Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix;
3. Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy;
4. At least one measurable lesion according to RECIST v1.1;
5. Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1;
6. Have adequate organ function.

Exclusion Criteria:

Subjects were excluded from the study if they met any of the following criteria:

1. Distant metastatic disease (including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 pyramid in the proximal cephalic region, according to FIGO 2018 stage IVB);
2. He had undergone total hysterectomy (removal of the corpus uteri and cervix);
3. Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities;
4. Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
5. Had any condition that was deemed by other investigators to be ineligible for participation in the trial.