Neoadjuvant toripalimab with platinum chemotherapy followed by chemoradiotherapy and toripalimab maintenance for locally advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective phase II trial enrolling women with previously untreated locally advanced cervical cancer to receive neoadjuvant platinum-based chemotherapy combined with the PD‑1 antibody toripalimab prior to standard concurrent chemoradiotherapy. Toripalimab is continued during concurrent chemoradiotherapy and given as maintenance afterwards. The approach is based on preclinical and early clinical data suggesting that giving immunotherapy before chemoradiotherapy may better preserve or boost anti-tumor T-cell responses than giving it concurrently or afterwards. The trial will measure tumor response and safety to determine whether this sequence merits a larger phase III trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute&Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Jie Chen
• Email: tjcjvip@126.com
• Phone: +86-18622221202

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.