Study on the Relationship Between Plasma MRD and cfDNA HPV and the Efficacy and Prognosis of Locally Advanced Cervical Cancer After Concurrent Chemoradiotherapy
Conditions: Locally Advanced Cervical Cancer
Sponsor: Guizhou Provincial People's Hospital

 
 
 
 
 
 
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Study on the relationship between plasma MRD and cfDNA 
HPV and the efficacy and prognosis of locally advanced 
cervical cancer after concurrent chemoradiotherapy 
 
 
 
Project Title: Relationship between plasma MRD and cfDNA HPV and efficacy 
and prognosis after concurrent chemoradiotherapy for 
locally advanced cervical cancer 
Project leader/principal investigator: Li Yong 
Department: Department of Oncology, Guizhou Provincial People's Hospital  
Project undertaking unit: Guizhou Provincial People's Hospital 
Project chair: Guizhou Provincial People's Hospital 
Project Year:2024/01 - 2026/12 
Version number: V1.0 
Version date: 2023-05-22 
 
 
 
  

 
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A. 、Purpose of the study 
1. Main objective: To detect the expression levels of MRD and plasma HPV 
before and after concurrent chemoradiotherapy for cervical cancer based on 
cfDNA liquid biopsy, and to evaluate the efficacy and recurrence risk of 
cervical cancer after concurrent chemoradiotherapy by the expression levels 
of MRD and plasma HPV 
2. Secondary objectives: To facilitate clinical decision-making on 
whether to adjuvant chemotherapy, as well as the timing of adjuvant 
chemotherapy and the benefits of adjuvant chemotherapy through the expression 
levels of MRD and plasma HPV.  
B. 、Types of study design, principles and procedures 
1. study design 
This is a prospective, observational, single-center study  
2. Study population and sample size considerations 
Study population: Cervical cancer patients diagnosed with initial visit to 
Guizhou Provincial People's Hospital from November 2022 to November 2024 were 
collected. 
Sample content estimation  
There were about 30 cases in the experimental group, and the sample 
estimation was estimated by Power and Sample Size Program software, α 0.05, 
Power 0.8, δ and σ were obtained according to the literature review, m was 
0.5.   
2.1 Inclusion Criteria: 
(1) Age: ≥ 18 years old, ≤ 75 years old.   
(2) Pathological histologic confirmation of cervical cancer.   
(3) Imaging or PET/CT examination can be performed to understand the tumor 

 
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and complete all follow-up.   
(4) Measurable lesions before treatment.   
(5) Good physical condition: ECOG score 0-1 (or KPS score 70-100).   
(6) Estimated survival≥ 6 months.   
(7) The baseline blood routine and biochemical indexes before radiotherapy 
and chemotherapy met the following standards: hemoglobin ≥ 80g/L, absolute 
neutrophil count (ANC) ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT, AST ≤ 
2.5 times the normal upper limit; Serum albumin ≥ 30 g/L.   
 (8) There are three preoperative items: if the patient has syphilis, plum 
repellent therapy is required before treatment.   
(9) The patient has no history of allergy to rubber products.   
(10) Cardiopulmonary function is basically normal  
 
2.2 Exclusion criteria： 
(1) Those who are allergic to rubber products.   
(2) Those with severe acute infection and uncontrolled or purulent and 
chronic infection wounds that do not heal, chronic hepatitis B active stage, 
active tuberculosis, syphilis outbreak and AIDS.   
(3) Patients with pre-existing severe heart disease, including: 
congestive heart failure, uncontrollable high-risk arrhythmia, unstable 
angina, myocardial infarction, severe valvular heart disease, and intractable 
hypertension.   
 (4) Those with neurological or psychiatric diseases or mental disorders 
that are not easy to control, poor compliance, unable to cooperate with and 
describe treatment responses, uncontrolled primary brain tumors or central 

 
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nervous system metastases, and those with obvious cranial hypertension signs 
or neuropsychiatric symptoms.   
(5) with malignant serous effusion.   
(6) History of severe enteritis and cystitis, bleeding, intestinal 
perforation, rectovaginal fistula, rectoval bladder fistula, etc.   
(7) Those who have participated in other clinical trials.   
(8) Other situations in which the investigator believes that the subject 
is not suitable to participate in this experiment.   
2.3Exit criteria： 
(1) The subject asked to withdraw from the study.   
(2) An irreversible accident occurs.   
 (3) Unable to effectively follow up with participants.   
(4) The investigator considers it necessary for the subject to abort the 
study from a medical point of view.   
(5) Other unforeseen circumstances.   
2.4 Termination of study criteria  
(1) The patient's condition is aggravated.   
(2) Occurrence of serious adverse events.   
(3) Poor patient compliance.   
3. Duration of the study 
   November 2022 to November 2024 
4. Research interventions 
This study was non-interventional. 
5. Study steps and related checks  
Before treatment: clear cervical pathology is required to confirm cervical 
cancer, complete imaging data, hematological data, laboratory test results 

 
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and comprehensive medical history.   
Treatment period: Complete standard treatment of cervical cancer 
(concurrent chemoradiotherapy).   
Follow-up period: Regular review at 4, 12 and 24 weeks after the end of 
treatment  
6. Use and preservation of biological samples  
Cervical tumor tissue was taken twice and made into wax blocks before 
treatment and during treatment (before the start of the first post-loading 
treatment); Clinically observe tumor retraction and monitor efficacy.   
5ml of peripheral blood was drawn 5 times, respectively, before treatment, 
during treatment (before the start of the first after-loading treatment), 4 
weeks, 12 weeks and 24 weeks after treatment, and serum and white blood cells 
were retained after treatment; Tested at Nanjing Shihe Medical Laboratory No. 
128 Huakang Road, Jiangbei New District, Nanjing 
7. Evaluation indicators/study endpoints  
The main endpoint indicators: the expression level and expression status of 
MRD and plasma HPV before, during, and 4, 12 and 24 weeks after treatment, 
the relationship between the expression level of MRD and plasma HPV expression 
status and the efficacy of concurrent chemoradiotherapy for cervical cancer, 
and the risk of recurrence after concurrent chemoradiotherapy for cervical 
cancer was predicted.   
Secondary endpoints: decision on whether to give adjuvant chemotherapy after 
the end of concurrent chemoradiotherapy for cervical cancer by the expression 
level of MRD and the expression status of plasma HPV, as well as the timing 
of chemotherapy and the benefit of chemotherapy 

 
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8. Visiting arrangements and data collection during the study  
From November 01, 2022 to November 31, 2024, 30 patients with newly treated 
cervical cancer admitted to Guizhou Provincial People's Hospital were included, 30 
cervical cancer tissue samples were collected before treatment and during treatment (before 
the start of the first afterload), and 5ml of peripheral blood of cervical cancer patients was 
collected before, during treatment (before the start of the first afterload), and 4 weeks, 12 
weeks and 24 weeks after the end of treatment to detect MRD expression levels. The 
relationship between the expression level of MRD and the expression status of HPV in 
plasma and the efficacy of cervical cancer treatment was analyzed.   
Thirty cases of cervical cancer were treated with concurrent chemoradiotherapy, and 
the efficacy was evaluated 4 weeks after the end of chemoradiotherapy, and the value of 
MRD expression level and plasma HPV expression status for clinically guided adjuvant 
chemotherapy and adjuvant chemotherapy time node and clinical benefit were evaluated.   
MRD and plasma HPV tests were performed 4 weeks, 12 weeks and 24 weeks after 
the end of concurrent chemoradiotherapy in 30 cases of cervical cancer to understand the 
risk of recurrence and predict prognosis. The expression level of MRD and the expression 
status of HPV in plasma and the clinical value of imaging results in predicting recurrence 
risk were compared.