Combining toripalimab with chemoradiotherapy for cervical cancer treatment

Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial

This study is testing if adding toripalimab to standard chemotherapy and radiation can help people with locally advanced cervical cancer do better than with just the usual treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: prednisone, toripalimab, pembrolizumab, chemotherapy
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT05084677 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of adding toripalimab, a PD-1 inhibitor, to concurrent platinum-based chemoradiotherapy in patients with locally advanced cervical cancer. The study aims to determine how this combination therapy impacts treatment outcomes compared to standard approaches. It is a single-arm, phase II trial that includes patients who have not received prior treatment for their condition. The trial will assess both the efficacy and tolerance of this combined treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are untreated patients aged 18 to 75 with pathologically confirmed locally advanced cervical cancer and an ECOG performance status of 0-1.

Not a fit: Patients with recurrent or metastatic disease or those with prior malignancies within the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with locally advanced cervical cancer.

How similar studies have performed: While there have been studies on PD-1 inhibitors in recurrent cervical cancer, the combination with concurrent chemoradiotherapy in locally advanced cases is relatively novel and less explored.

Eligibility criteria

Inclusion Criteria:

* Age between 18 and 75;
* Untreated patients with pathologically proven locally advanced cervical cancer;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Adequate hematological, renal and hepatic functions:

  1. Hemoglobin \> 8.0 g/dl
  2. Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L
  3. Platelets \> 100 × 109/L

  g. Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) d. Serum ALT/AST ≤ 2.5× UNL e. Serum Total bilirubin ≤ 1.5× UNL
* Life expectancy \> 6 months
* Eligible for concurrent chemoradiotherapy assessed by principle investigator;
* No obvious active bleeding;
* Written informed consent must be available before study registration

Exclusion Criteria:

* Recurrent or distant metastatic disease;
* Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
* Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
* Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
* Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
* Previous organ transplantation or HIV patients;
* Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
* Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.

Where this trial is running

Tianjin, Tianjin

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

Study contacts

• Study coordinator: Jie Chen

Conditions Cervical Cancer