Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer

NCT05511623 | Recruiting Phase 2

• 1 other identifier: W2022
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.

Conditions

Cervical Cancer

Keywords

cervical carcinoma; PD-1; chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• 3-year progress free survival rate

  Progression-free survival (PFS) is defined as the time between entry into the study and progression of the tumor (in any respect) or death (from any cause).

  up to 3 years

• side effect rate

  Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  up to 3 years

Secondary Outcomes (2)

• Objective response rate(ORR)

  3 months, after chemoradiotherapy

• 3-year overall survival rate

  up to 3 years

Study Arms (2)

tislelizumab

EXPERIMENTAL

The external radiation is administered at 45-50Gy/25f and brachytherapy is performed sequentially at 6Gy/time to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg/m2 on day 1 once every week for 5 weeks. In addition, patients also receive tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.

Drug: tislelizumab

concurrent chemoradiotherapy

ACTIVE COMPARATOR

The external radiation is administered at 45-50Gy/25f and brachytherapy is performed sequentially at 6Gy/time to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg/m2 on day 1 once every week for 5 weeks.

Other: concurrent chemoradiotherapy

Interventions

tislelizumab DRUG

standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.

Also known as: pd-1 antibody

tislelizumab

concurrent chemoradiotherapy OTHER

standard radiotherapy with concomitant cisplatin 40mg/m2 on day 1 once every week for 5 weeks.

Also known as: DDP combined with radiotherapy

concurrent chemoradiotherapy

Eligibility Criteria

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

You may qualify if:

• (1)18-70 years old; (2)Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; (3)Patients with 2018 FIGO stage IIIC2 cervical cancer; (4)At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; (5)Eastern Cooperative Oncology Group score 0-1; (6)No metastatic diseases; (7)Must have an average life expectancy of 6 months; (8)Participants must have normal organ and marrow function as defined below: (hemoglobin ≥90g/L,neutrophils ≥1.5×109/L, platelets ≥80×109/L, ALB≥30g/L, Total bilirubin≤1.5 x institutional upper limit of normal, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, Creatinine clearance≥60 mL/min; (9)Patients with menopause, or patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative pregnancy test result, non-lactating women; (10)Patients volunteered to participate in the study and sign the informed consent.

You may not qualify if:

• Diagnosed with any other cancer within the past 5 years;
• Known allergy to any component of the drug;
• Congenital or acquired immune deficiency (such as HIV infection);
• The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); Medical history of vitiligo; asthma which requires bronchodilators for medical intervention;
• Active infection requiring systemic treatment;
• Previously treatment with PD-1 and/or PD-L1, or CTLA-4 antibody, or other medications targeting immunomodulatory receptors;
• Patients with grade\>2 unrelieved toxic reactions (based on National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) caused by any previous treatment;
• With a history of myocardial infarction,stroke, unstable angina, decompensated heart failure, or deep vein thrombosis;
• Long-term uncured wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks;
• Pregnant or lactating women;
• With metastatic diseases;
• Liver/renal insufficiency;
• Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders;
• Those who have participated in clinical trials with other drugs within 4 weeks;
• Patients with concomitant diseases or abnormal test results which interfere with the ability to receive anticancer therapy judged by the investigator;

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

tislelizumab; spartalizumab; Chemoradiotherapy; Radiotherapy

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• fang wu, M.D.

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shanshan ma, M.D.

CONTACT

07715356509; 56716690@qq.com

yong zhang, M.D.

CONTACT

07715356509; zhangyonggx@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized (1:1) to Arm A or Arm B.

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: August 23, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)