Clinical trial NCT05084677: Toripalimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer
Official title: Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent platinum-based chemoradiotherapy in patients with locally advanced cervical cancer.

Detailed description: Up to now, there have been several prospective studies exploring the effectiveness of PD-1 inhibitors in patients with recurrent/ metastatic cervical cancer. The results showed that the overall objective response rate (ORR) was between 12.2% and 55.6%, and pembrolizumab was approved by the US Food and Drug Administration for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy. However, the evidence of using PD-1 inhibitors together with concurrent chemotheradiotherapy in patients with locally advanced cervical cancer is rare, so we initiated this single arm prospective phase II clinical study. The purpose is to explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

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.

Primary outcomes:
measure: Overall response rate
timeFrame: 1 year
Secondary outcomes:
measure: Progression free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute&Hospital
state: Tianjin
Study officials:
References:
citation: Chen J, Li C, Cao Y, Zhu L, Zhang B, You J, Hou H, Wang J, Yuan Z. Toripalimab combined with concurrent platinum-based Chemoradiotherapy in patients with locally advanced cervical Cancer: an open-label, single-arm, phase II trial. BMC Cancer. 2022 Jul 19;22(1):793. doi: 10.1186/s12885-022-09866-w.