Tislelizumab Combing Chemoradiotherapy in Recurrent Cervical Cancer

NCT05863260 | Unknown

• 1 other identifier: PILOT-2020-511
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Cancer; Immune Checkpoint Inhibitor; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate

  1 year

Secondary Outcomes (2)

• 1-year PFS

  1 year

• 1-year OS

  1 year

Study Arms (1)

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

Treatment Group DRUG

Treatment Group

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;
• Cervical adenocarcinoma, squamous cell carcinoma or adenosquamous cell carcinoma confirmed by previous histology;
• Surgical resection is not recommended for recurrent lesions, or patients choose not to accept surgery voluntarily;
• The researchers evaluated the suitability of radiotherapy
• ECoG 0-1; life expectancy \> 6 months;
• Aged 18-70 years;
• No serious allergic history;
• 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;
• Ability to sign informed consent.

You may not qualify if:

• Histologically, small cell (neuroendocrine) cervical cancer, mucinous adenocarcinoma, carcinosarcoma and other pathological types were confirmed;
• 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.
• The recurrent lesions have received chemotherapy, radiotherapy or other anti-tumor treatment;
• Bone metastasis;
• Brain metastasis;
• Pregnant or lactating patients;
• 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;
• 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;
• Patients with active autoimmune diseases need systemic treatment in the past 2 years;
• A history of (noninfectious) pneumonia requiring steroids or current pneumonia;
• There are active infections that need systematic treatment;
• Known history of human immunodeficiency virus (HIV) infection;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: November 9, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

CN (1)