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

Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial

This treatment plan tests whether giving toripalimab with platinum chemotherapy before, during, and after chemoradiotherapy helps women with locally advanced cervical cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: ipilimumab, prednisone, toripalimab, camrelizumab, chemotherapy, immunotherapy
• Locations: 1 site (Tianjin)
• Trial ID: NCT07092696 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 18–75 with newly diagnosed, previously untreated locally advanced squamous, adenocarcinoma, or adenosquamous cervical cancer who have at least one measurable lesion, ECOG 0–1, adequate blood counts, and eligibility for concurrent chemoradiotherapy are the intended participants.

Not a fit: Patients with distant metastases, prior therapy for the current cervical cancer, poor performance status, significant active bleeding, or inadequate laboratory values are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could raise tumor response rates and extend disease control while maintaining an acceptable safety profile.

How similar studies have performed: Early clinical reports, including a 2024 ASCO presentation of neoadjuvant camrelizumab plus chemotherapy followed by chemoradiotherapy, reported high response rates and acceptable safety, indicating this neoadjuvant-first immunotherapy approach is promising but requires confirmation.

Eligibility criteria

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 this trial is running

Tianjin

• Tianjin Medical University Cancer Institute&Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Jie Chen

Conditions Cervical Cancer