search
Back to results

Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

Primary Purpose

Cervical Cancer, Induction Chemotherapy, Immunotherapy

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring cervical cancer, immunotherapy, neoadjuvant chemotherapy, chemoradiation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Untreated locally advanced cervical cancer patients with clear pathological diagnosis 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Life expectancy > 6 months Able to tolerate concurrent chemoradiotherapy assessed by researches No obvious active bleeding; Adequate hematological, renal and hepatic functions: No concomitant malignancies Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period; Voluntarily-signed informed consent. Exclusion Criteria: Concomitant other malignancies; Patients with metastatic or recurrent disease; Patients received any form of treatment before enrollment; Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections; Impaired hematological, renal or hepatic functions: Hemoglobin < 9.0 g/dl Neutrophils < 2000 cells/μl; Leukocytes < 4 × 109/L Platelets > 100 × 109/L Serum ALT/AST > 2.5×UNL 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) Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease; Patients with uncontrolled mental diseases; Pregnant or lactating woman; Participating in other clinical trials; Anyone considered not suitable for enrollment by principal investigator;

Sites / Locations

  • Tianjin Medical University Cancer Institute & HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction immunotherapy and chemotherapy

Arm Description

Patients enrolled in this arm would receive neoadjuvant immunotherapy and chemotherapy before definitive chemoradiation

Outcomes

Primary Outcome Measures

Overall response rate
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
Volume changes of core radiation targets and irradiated normal tissues after induction treatment
Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50

Secondary Outcome Measures

Progression-free survival
Time from diagnosis of disease to disease progression or death due to any cause
Distant metastasis-free survival
Time from diagnosis to distant metastasis or death due to any cause
Incidence of treatment-related side effects
Incidence of treatment-related side effects (i.e., radiation-related proctitis, cystitis, ,vaginitis, etc.)

Full Information

First Posted
October 9, 2023
Last Updated
October 16, 2023
Sponsor
Tianjin Medical University Cancer Institute and Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06093438
Brief Title
Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer
Official Title
Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Induction Chemotherapy, Immunotherapy
Keywords
cervical cancer, immunotherapy, neoadjuvant chemotherapy, chemoradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction immunotherapy and chemotherapy
Arm Type
Experimental
Arm Description
Patients enrolled in this arm would receive neoadjuvant immunotherapy and chemotherapy before definitive chemoradiation
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Intervention Description
Patients enrolled in this arm would receive three cycles of induction treatment before receiving definitive chemoradiotherapy. The specific regimen is: Paclitaxel(135mg/m2,ivd, d1)+cisplatin(75mg/m2,ivd,d1-3)+Toripalimab (240mg,ivd,d1)±bevacizumab(ivd, d1)/q21d. Patients would receive pelvic MRI to evaluate the regression status of tumor after three cycles of induction treatment. Patients with satisfying tumor regression would receive definitive chemoradiotherapy afterwards. During chemoradiotherapy, patients would receive weekly cisplatin (40mg/m2) and 240mg toripalimab every three weeks. After chemoradiotherapy, patients would receive another three cycles of consolidated treatment (regimen identical to induction treatment).
Primary Outcome Measure Information:
Title
Overall response rate
Description
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
Time Frame
1 year
Title
Volume changes of core radiation targets and irradiated normal tissues after induction treatment
Description
Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50
Time Frame
5-year
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Time from diagnosis of disease to disease progression or death due to any cause
Time Frame
1-year, 2-year
Title
Distant metastasis-free survival
Description
Time from diagnosis to distant metastasis or death due to any cause
Time Frame
1-year, 2-year
Title
Incidence of treatment-related side effects
Description
Incidence of treatment-related side effects (i.e., radiation-related proctitis, cystitis, ,vaginitis, etc.)
Time Frame
5-year

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Untreated locally advanced cervical cancer patients with clear pathological diagnosis 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Life expectancy > 6 months Able to tolerate concurrent chemoradiotherapy assessed by researches No obvious active bleeding; Adequate hematological, renal and hepatic functions: No concomitant malignancies Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period; Voluntarily-signed informed consent. Exclusion Criteria: Concomitant other malignancies; Patients with metastatic or recurrent disease; Patients received any form of treatment before enrollment; Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections; Impaired hematological, renal or hepatic functions: Hemoglobin < 9.0 g/dl Neutrophils < 2000 cells/μl; Leukocytes < 4 × 109/L Platelets > 100 × 109/L Serum ALT/AST > 2.5×UNL 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) Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease; Patients with uncontrolled mental diseases; Pregnant or lactating woman; Participating in other clinical trials; Anyone considered not suitable for enrollment by principal investigator;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanjie Cao
Phone
+86-18522123151
Email
cyjro325@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Li
Phone
+86-15510932601
Email
lichen.radonco@tmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Chen
Organizational Affiliation
Tianjin Medical University Cancer Institute & Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

We'll reach out to this number within 24 hrs