Tislelizumab Combing Chemoradiotherapy in Recurrent Cervical Cancer

NCT ID: NCT05863260

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2024-12-31

Brief 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

Conditions

Cervical Cancer; Immune Checkpoint Inhibitor; Chemoradiotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention

Paclitaxel 135mg / m2d1 + cisplatin 60mg / m2d1 (cisplatin resistance or cisplatin intolerance changed to carboplatin AUC = 5d1), q3w × 4 and Standard IMRT and radiotherapyTislelizumab 200mg, IV, q3w, the day before radiotherapy

Treatment Group

Intervention Type: DRUG

Treatment Group

Interventions

Treatment Group

Treatment Group

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

JUN ZHU, M.D.

Role: primary

dragonzld@163.com

8613564972482

Other Identifiers

PILOT-2020-511

Identifier Type: -

Identifier Source: org_study_id