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Trial Title:
Tislelizumab Combing Chemoradiotherapy in Recurrent Cervical Cancer
NCT ID:
NCT05863260
Condition:
Cervical Cancer
Immune Checkpoint Inhibitor
Chemoradiotherapy
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Treatment Group
Description:
Treatment Group
Arm group label:
Intervention
Summary:
Tislelizumab combined with chemoradiotherapy in the treatment of recurrent/ metastasis
cervical cancer: a single arm,single center， phase ii and observational clinical study
Detailed description:
Tislelizumab combined with chemoradiotherapy in the treatment of recurrent/ metastasis
cervical cancer: a single arm,single center， phase ii and observational clinical study
Criteria for eligibility:
Study pop:
Patients with recurrent or metastatic cervical cancer after initial standard treatment
(including radical surgery or radical radiotherapy), the lesions are located out of the
field of previous radiotherapy, with no more than 5 recurrent or metastatic foci, and the
radiotherapy is feasible according to the evaluation of radiotherapy physician; and at
least 1 lesion (without previous radiotherapy) meets the target lesion standard of RECIST
1.1
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. For patients with recurrent or metastatic cervical cancer after initial standard
treatment (including radical surgery or radical radiotherapy), the lesions are
located out of the field of previous radiotherapy, with no more than 5 recurrent or
metastatic foci, and the radiotherapy is feasible according to the evaluation of
radiotherapy physician; and at least 1 lesion (without previous radiotherapy) meets
the target lesion standard of RECIST 1.1;
2. Cervical adenocarcinoma, squamous cell carcinoma or adenosquamous cell carcinoma
confirmed by previous histology;
3. Surgical resection is not recommended for recurrent lesions, or patients choose not
to accept surgery voluntarily;
4. The researchers evaluated the suitability of radiotherapy
5. ECoG 0-1; life expectancy > 6 months;
6. Aged 18-70 years;
7. No serious allergic history;
8. Hemoglobin > 100 g / L, WBC > 3.5 * 10 ^ 9 / L, neutrophils > 1.5 * 10 ^ 9 / L,
platelets > 100 * 10 ^ 9 / L, Cr < 1.5 * normal upper limit, TB < 2.5 * normal upper
limit, AST and Al < 2.5 * normal upper limit, AKP < 2.5 * normal upper limit;
9. Ability to sign informed consent.
Exclusion Criteria:
1. Histologically, small cell (neuroendocrine) cervical cancer, mucinous
adenocarcinoma, carcinosarcoma and other pathological types were confirmed;
2. Primary malignant tumor with activity in other parts, except for the following:
Those who have been cured have no known active disease at least 5 years before the
first IP administration, and the potential risk of recurrence is low;
Fully treat non melanoma skin cancer or malignant nevus without disease signs;
Fully treated carcinoma in situ, no signs of disease.
3. The recurrent lesions have received chemotherapy, radiotherapy or other anti-tumor
treatment;
4. Bone metastasis;
5. Brain metastasis;
6. Pregnant or lactating patients;
7. In the past, there was abnormal thyroid function, and under the condition of drug
treatment, thyroid function could not be maintained in the normal range;
8. Diagnosis of immune deficiency or treatment with chronic systemic steroids (doses
more than 10 mg per day of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days before enrollment;
9. Patients with active autoimmune diseases need systemic treatment in the past 2
years;
10. A history of (noninfectious) pneumonia requiring steroids or current pneumonia;
11. There are active infections that need systematic treatment;
12. Known history of human immunodeficiency virus (HIV) infection;
13. Known history of hepatitis B or known active hepatitis C virus infection;
14. Known history of active tuberculosis (TB);
15. Uncontrolled comorbidities, including but not limited to: persistent or active
infection, symptomatic congestive heart failure, uncontrolled hypertension,
uncontrolled diabetes, uncontrolled arrhythmias, active interstitial lung disease
(ILD), severe chronic gastrointestinal disease with diarrhea, or may limit
compliance with study requirements, leading to AE Mental / social problems that
significantly increase or affect the ability of subjects to provide written informed
consent;
16. 14 days before admission, the operation was too large and had not recovered;
17. Participate in other clinical trials at present or within 28 days before selection;
18. Any indications, including but not limited to other anti-CTLA-4, anti-PD-1,
anti-PD-L1 and anti-PD-L2 antibodies or therapeutic anti-cancer vaccines, were
treated by immunomediated therapy prior to the study;
19. Any synchronous chemotherapy, research drug, biological product, or hormone therapy
used to treat tumors. Hormone therapy can also be used to treat non tumor related
diseases (e.g., hormone replacement therapy);
20. Allogeneic tissue / solid organ transplantation was carried out.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
JUN ZHU, M.D.
Phone:
8613564972482
Email:
dragonzld@163.com
Start date:
November 9, 2020
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05863260
