Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

Last updated: March 6, 2025
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cervical Cancer

Vaginal Cancer

Chemotherapy

Treatment

Toripalimab

Clinical Study ID

NCT06093438
2020230207083952035
  • Ages 18-75
  • Female

Study Summary

To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Untreated locally advanced cervical cancer patients with clear pathologicaldiagnosis

  2. 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameterof their metastatic lymph nodes should ≥1.5cm

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

  4. Life expectancy > 6 months

  5. Able to tolerate concurrent chemoradiotherapy assessed by researches

  6. No obvious active bleeding;

  7. Adequate hematological, renal and hepatic functions:

  8. No concomitant malignancies

  9. Female subjects of childbearing potential should have a negative pregnancy test andmust take effective and reliable contraceptive measures during the clinical trialperiod;

  10. Voluntarily-signed informed consent.

Exclusion

Exclusion Criteria:

  1. Concomitant other malignancies;

  2. Patients with metastatic or recurrent disease;

  3. Patients received any form of treatment before enrollment;

  4. Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acuteinfections;

  5. Impaired hematological, renal or hepatic functions:

  6. Hemoglobin < 9.0 g/dl

  7. Neutrophils < 2000 cells/μl; Leukocytes < 4 × 109/L

  8. Platelets > 100 × 109/L

  9. Serum ALT/AST > 2.5×UNL

  10. Serum Total bilirubin > 1.5× UNL g. Serum urea nitrogen (BUN) > 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) > 1.5 × upper normal limit (UNL)

  11. Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricularblock, cardiac insufficiency or severe heart valve disease;

  12. Patients with uncontrolled mental diseases;

  13. Pregnant or lactating woman;

  14. Participating in other clinical trials;

  15. Anyone considered not suitable for enrollment by principal investigator;

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Toripalimab
Phase: 1/2
Study Start date:
November 01, 2023
Estimated Completion Date:
July 01, 2026

Study Description

For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.

Connect with a study center

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

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