Toripalimab Combined With Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk Locally Advanced Cervical Cancer: the Phase II Single-arm TorCH -CC Study
This phase II clinical study assesses the efficacy and safety of Toripalimab combined with chemoradiotherapy (CRT) followed by Toripalimab maintenance in treating high-risk locally advanced cervical cancer (HR-LACC). Despite CRT being the standard treatment, HR-LACC patients face poor survival outcomes. Toripalimab, a cost-effective PD-1 inhibitor, has shown promise in prior research. The primary endpoint is 2-year progression-free survival, with the study aiming to improve treatment accessibility and patient prognoses in China.
• Patients with histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
• FIGO 2018 staging criteria classifying the disease as stages III-IVA.
• Age range from 18 to 70 years inclusive.
• No prior receipt of surgery, radiotherapy, or systemic anticancer therapy for the treatment of cervical cancer.
• No previous exposure to the study drug.
• Presence of at least one measurable or evaluable lesion as per RECIST version 1.1, with the measurable lesion exhibiting a longest diameter of ≥10 mm on spiral CT scan or a shortest diameter of ≥15 mm for enlarged lymph nodes, which has not been previously irradiated.
• Absence of central nervous system diseases, both primary and metastatic.
• WHO/ECOG performance status score of 0-1.
• Anticipated survival duration of at least 12 weeks.
⁃ Adequate organ function within the following parameters (without the use of any blood components, cytokines, or growth factors within 14 days prior to randomization):
∙ Absolute neutrophil count (ANC) ≥1.5×10\^9/L
‣ Platelet count ≥90×10\^9/L
‣ Hemoglobin level ≥90 g/L
‣ Serum albumin level ≥30 g/L
‣ Bilirubin level ≤1.5 times the upper limit of normal (ULN)
‣ Alanine transaminase (ALT) and aspartate transaminase (AST) levels ≤3×ULN
‣ Serum creatinine level ≤1.5×ULN
‣ Thyroid-stimulating hormone (TSH) level ≤1×ULN (with eligibility also extended to patients with free triiodothyronine \[FT3\] or free thyroxine \[FT4\] levels ≤1×ULN).
⁃ For women of childbearing potential not undergoing surgical sterilization, a negative serum pregnancy test (hCG) within 72 hours prior to study randomization is required; breastfeeding must be absent. Additionally, the use of a medically approved contraceptive method is mandatory from the time of informed consent through the study treatment period and for 120 days following the final administration of the trial medication or 180 days after the last chemotherapy/radiotherapy session. Participants must also agree not to donate eggs for reproductive purposes or to freeze/preserve eggs for this use during the aforementioned period.
⁃ Provision of a tumor tissue biopsy specimen is mandatory.
⁃ Informed consent must be obtained with documentation.
⁃ Availability for follow-up assessments.