Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer

Summary

To explore the efficacy and tolerability of a platinum-based regimen combined with the PD-1 antibody toripalimab administered prior to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

Eligibility

Inclusion Criteria:

* Women aged 18-75 years.

  * Histologically confirmed, previously untreated locally advanced cervical cancer of squamous, adenocarcinoma, or adenosquamous type.
  * At least one measurable lesion that has not received prior local therapy (non-nodal lesion ≥ 10 mm longest diameter or pathological lymph node ≥ 15 mm short axis, per RECIST 1.1).
  * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
  * Estimated life expectancy ≥ 6 months.
  * Investigator-assessed eligibility for concurrent chemoradiotherapy.
  * No clinically significant active bleeding.
  * Laboratory values: WBC \> 4 × 10⁹/L; platelets \> 100 × 10⁹/L.
  * No history of other malignancies.
  * Women of child-bearing potential must have a negative serum pregnancy test and use effective contraception throughout the study.
  * Written informed consent obtained prior to any study-related procedures.

Exclusion Criteria:

* Tumor recurrence or distant metastasis at screening.

  * Active autoimmune disease requiring systemic therapy, or any chronic condition requiring long-term high-dose corticosteroids (≥10 mg/day prednisone or equivalent) or other immunosuppressive agents.
  * Systemic corticosteroids (\>10 mg/day prednisone or equivalent) or any other immunosuppressive drugs within 14 days before first study dose or anticipated during the study.
  * Live-attenuated vaccination within 30 days before first dose or planned during the study.
  * Prior organ transplantation or known HIV infection.
  * Active hepatitis B (HBV DNA \>2000 IU/mL or \>10⁴ copies/mL, or HBsAg positive) or active hepatitis C (HCV RNA \>10³ copies/mL); co-infection with both viruses is also excluded.
  * Prior therapy with any agent targeting PD-1, PD-L1, PD-L2, CD137, CTLA-4 (e.g., ipilimumab), or any other antibody or drug that modulates T-cell co-stimulation or checkpoint pathways.
  * Known hypersensitivity to monoclonal antibodies, fusion proteins, or any excipients in the investigational products.
  * History of another malignancy within the past 5 years, except adequately treated cervical carcinoma in situ, basal-cell carcinoma of the skin, or other localized malignancies considered cured.
  * Severe non-surgical comorbidity or acute infection.
  * Peripheral neuropathy \> Grade 1 (NCI-CTCAE).
  * Inadequate hematologic or organ function:
  * WBC \< 4.0 × 10⁹/L, ANC \< 1.5 × 10⁹/L, platelets \< 100 × 10⁹/L, Hb \< 90 g/L
  * TBIL \> 1.5 × ULN, ALT/AST \> 2.5 × ULN, BUN \> 1.5 × ULN, creatinine \> 1.5 × ULN
  * Symptomatic brain metastases.
  * Clinically significant cardiac arrhythmias, myocardial ischemia, severe conduction block, heart failure, or severe valvular disease.
  * Severe bone-marrow failure.
  * Uncontrolled psychiatric illness.
  * Pregnant or lactating women.
  * Investigator-judged unsuitability for the trial.
  * Concurrent participation in another interventional clinical study.

Conditions2

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