search
Back to results

Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Neoadjuvant Therapy
CCRT
Brachytherapy
Sponsored by
Sichuan Cancer Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥18 years old
  • Patients must have histologically confirmed cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 Ib3-IIIc2.
  • According to the RECIST 1.1 standard, the subject must have at least one measurable target lesion
  • No prior treatment
  • Expected survival period ≥ 3 months
  • ECOG score: 0-1
  • No obvious signs of hematological diseases, ANC≥1.5×10^9/L, platelet count≥100×10^9/L, Hb≥90g/L, WBC≥3.0×10^9/L, and no bleeding tendency before enrollment;
  • Adequate hepato-renal function is needed, including: Total bilirubin (TBIL)≤1.5×ULN (Gilbert syndrome allows ≤5×ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN Serum creatinine (Cr) ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50mL/min
  • Cardiac Function: left ventricular ejection fraction (LVEF) >=50%;
  • Patients voluntarily participated in the study and signed informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding female patients (women of child-bearing potential must confirm that the pregnancy test is negative within 7 days before the first administration. If it is positive, ultrasound examination must be performed to exclude pregnancy), or women of child-bearing potential who refused to receive contraceptive measures
  • Combined with other malignant tumors, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part
  • Existence of any bone marrow dysplasia and other abnormal hematopoietic diseases
  • Active infections, HIV infections, and viral hepatitis that require systematic treatment
  • Patients with≥Grade 1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 5.0
  • Had severe cardiovascular diseases such as cerebrovascular accident, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4) and arrhythmia that need drug intervention within 6 months
  • It is known to have a history of allergies to research drugs or drug components
  • Has clinically significant thyroid dysfunction before enrollment;
  • Has participated in other anti-tumor intervention clinical trials within 30 days before the first medication
  • Have a clear history of dementia, mental state changes or any mental illness that will hinder understanding or informed consent
  • The investigator believes that the patient is not suitable for participating in this clinical research

Sites / Locations

  • Sicchuan cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental: Neoadjuvant Therapy+CCRT

Experimental: CCRT alone

Arm Description

Patients will be treated with 2 cycles of neoadjuvant chemotherapy (Cisplatin 50 mg/m^2 d1 q21+ Paclitaxel 175 mg/m^2 d1 q21) combined with serplulimab （300mg d1 q21）. After that, weekly cisplatin 30mg/m^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes. The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors. All radiotherapy should be completed within eight weeks.

weekly cisplatin 40mg/m^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes. The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors. All radiotherapy should be completed within eight weeks.

Outcomes

Primary Outcome Measures

Progression free survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.

Secondary Outcome Measures

Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

Full Information

First Posted
December 26, 2021
Last Updated
May 31, 2023
Sponsor
Sichuan Cancer Hospital and Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05173272
Brief Title
Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer
Official Title
A Prospective Randomized Controlled Trials of Neoadjuvant Chemotherapy Combined With Serplulimab Followed by Concurrent Chemoradiation Versus Concurrent Chemoradiation Therapy Alone in Advanced Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 28, 2027 (Anticipated)
Study Completion Date
December 28, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute

4. Oversight

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

5. Study Description

Brief Summary
The main objective of this study is to determine whether neoadjuvant chemotherapy combined with slulimumab sequential concurrent chemoradiotherapy versus concurrent chemoradiotherapy for locally advanced cervical cancer could improve progression-free survival rates. Women in the experimental arm will receive neoadjuvant chemotherapy (cisplatin plus paclitaxel) combined with slulimumab every 21 days during 2 cycles followed by concurrent chemoradiation therapy. Women in the control arm will receive concurrent chemoradiation therapy alone. 286 patients will be recruited during 2 years, with 3 years of follow up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Neoadjuvant Therapy+CCRT
Arm Type
Experimental
Arm Description
Patients will be treated with 2 cycles of neoadjuvant chemotherapy (Cisplatin 50 mg/m^2 d1 q21+ Paclitaxel 175 mg/m^2 d1 q21) combined with serplulimab （300mg d1 q21）. After that, weekly cisplatin 30mg/m^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes. The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors. All radiotherapy should be completed within eight weeks.
Arm Title
Experimental: CCRT alone
Arm Type
Experimental
Arm Description
weekly cisplatin 40mg/m^2 for 4 or 5 weeks is administered concomitant with external beam radiotherapy (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes. The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors. All radiotherapy should be completed within eight weeks.
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant Therapy
Other Intervention Name(s)
Neoadjuvant chemotherapy combined with Serplulimab
Intervention Description
Cisplatin 50 mg/m^2 d1 q21+ Paclitaxel 175 mg/m^2 d1 q21+serplulimab 300mg d1 q21
Intervention Type
Radiation
Intervention Name(s)
CCRT
Other Intervention Name(s)
chemoradiation
Intervention Description
weekly cisplatin for 4 or 5 weeks is administered concomitant with EBRT (45-50.4Gy) in 1.8-2 daily fractions and a 10-20 Gy boost to reach a total dose of 65 Gy when there was unresectable lymph nodes.
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy
Intervention Description
The primary cervical tumor is the boosted, using image guided 3D brachytherapy or 2D brachytherapy, with an additional 30-40 Gy to HRCTV (3D brachytherapy) or to point A (2D brachytherapy), to achieve a total dose of 80 Gy for small-volume cervical tumors or 85 Gy for larger-volume cervical tumors.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.
Time Frame
Up to approximately 36 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is the time from randomization to death due to any cause.
Time Frame
Up to approximately 48 months
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.
Time Frame
Up to approximately 36 months
Title
Number of Participants Who Experience One or More Adverse Events (AEs)
Description
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time Frame
Up to approximately 36 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old Patients must have histologically confirmed cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 Ib3-IIIc2. According to the RECIST 1.1 standard, the subject must have at least one measurable target lesion No prior treatment Expected survival period ≥ 3 months ECOG score: 0-1 No obvious signs of hematological diseases, ANC≥1.5×10^9/L, platelet count≥100×10^9/L, Hb≥90g/L, WBC≥3.0×10^9/L, and no bleeding tendency before enrollment; Adequate hepato-renal function is needed, including: Total bilirubin (TBIL)≤1.5×ULN (Gilbert syndrome allows ≤5×ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN Serum creatinine (Cr) ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50mL/min Cardiac Function: left ventricular ejection fraction (LVEF) >=50%; Patients voluntarily participated in the study and signed informed consent Exclusion Criteria: Pregnant or breastfeeding female patients (women of child-bearing potential must confirm that the pregnancy test is negative within 7 days before the first administration. If it is positive, ultrasound examination must be performed to exclude pregnancy), or women of child-bearing potential who refused to receive contraceptive measures Combined with other malignant tumors, except for cured skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of any other part Existence of any bone marrow dysplasia and other abnormal hematopoietic diseases Active infections, HIV infections, and viral hepatitis that require systematic treatment Patients with≥Grade 1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 5.0 Had severe cardiovascular diseases such as cerebrovascular accident, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4) and arrhythmia that need drug intervention within 6 months It is known to have a history of allergies to research drugs or drug components Has clinically significant thyroid dysfunction before enrollment; Has participated in other anti-tumor intervention clinical trials within 30 days before the first medication Have a clear history of dementia, mental state changes or any mental illness that will hinder understanding or informed consent The investigator believes that the patient is not suitable for participating in this clinical research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guonan Zhang
Phone
86-13881866599
Email
zhanggn@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Liu
Phone
86-13693447854
Email
liuhaotian12@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guonan Zhang
Organizational Affiliation
Sichuan Cancer Hospital and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sicchuan cancer hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guonan Zhang
Phone
86-13881866599
Email
zhanggn@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hong Liu
Phone
86-13693447854

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Induction Chemotherapy Combined With Immunotherapy Followed by Concurrent Chemoradiation in Advanced Cervical Cancer

We'll reach out to this number within 24 hrs