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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFirst Affiliated Hospital of Guangxi Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • concurrent chemoradiotherapy

    Other intervention

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

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: tislelizumabExperimental treatment 1 intervention
Group B: concurrent chemoradiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
up to 3 years
2

side effect rate

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

Time frame
up to 3 years

Secondary outcomes

1

Objective response rate(ORR)

ORR is defined as the proportion of patients with CR or PR, assessed by RECIST v1.1 per independent central radiologic review.

Time frame
3 months, after chemoradiotherapy
2

3-year overall survival rate

overall survival rate(OS)is calculated from the date of entry into the study to the date of death or the last follow-up visit.

Time frame
up to 3 years

Other outcomes

Sponsors and contacts

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