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RecruitingNCT05863260Updated May 18, 2023

Tislelizumab Combing Chemoradiotherapy in Recurrent Cervical Cancer

An observational study in Cervical Cancer, Immune Checkpoint Inhibitor and Chemoradiotherapy, sponsored by Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-18.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Nov 2020; still recruiting 5 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

Tislelizumab combined with chemoradiotherapy in the treatment of recurrent/ metastasis cervical cancer: a single arm,single center, phase ii and observational clinical study

Read the 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

02

Conditions studied

  • Cervical Cancer
  • Immune Checkpoint Inhibitor
  • Chemoradiotherapy
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 60 is below the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Drug: Treatment Group

Interventions

  • DrugTreatment Group

    Treatment Group

06

What researchers measure

Primary outcomes

  1. ORR

    Objective response rate

    Time frame: 1 year

Secondary outcomes

  1. 1-year PFS

    1-year PFS

    Time frame: 1 year

  2. 1-year OS

    1-year OS

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05863260
Lead sponsor
Fudan University
Responsible party
Jun Zhu (Professor, Fudan University) — Principal investigator
First posted
May 18, 2023
Start date
Nov 9, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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