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Efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer

Efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032856
Enrollment
Unknown
Registered
2020-05-13
Start date
2020-05-13
Completion date
Unknown
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced cervical cancer

Interventions

experimental group:1. Tislelizumab 200mg, IV, 1 day before radiotherapy, q3w Until the disease progresses / or lasts for 1 year
2. concurrent chemoradiotherapy.

Sponsors

Suzhou Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with stage II a2 - IV a (2018 FIGO stage) locally advanced cervical cancer; 2. Patients with ECoG grade 0-1; life expectancy > 6 months; 3. Patients aged 18-70 years; 4. Patients who did not use chemotherapy before being selected; 5. Patients without radiotherapy history; 6. Patients without surgery; 7. Patients without serious allergic history; 8. Hemoglobin >= 100 g / L, WBC >= Three point five x 10 ^ 9 / L, neutrophils >= One point five x 10 ^ 9 / L, platelet >= 100 x 10 ^ 9 / L; Cr <= One point five Times normal upper limit, TB <= two point five Times normal upper limit, AST and alt <= Two point five Times normal upper limit, AKP <= Two point five Times of normal upper limit; 9. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with history of malignant tumor in other parts; 2. Pregnant or lactating patients; 3. Patients with a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or organ transplantation; 4. Patients with previous thyroid dysfunction, and in the case of drug treatment, thyroid function still can not be maintained in the normal range; 5. Patients in the active stage of infectious diseases; 6. Patients participating in other clinical trials at present or within four weeks before selection; 7. Patients treated with other anti-cancer drugs (including anti-cancer traditional Chinese Medicine) at the same time.

Design outcomes

Primary

MeasureTime frame
3-year LRFFS%;3-year PFS%;LRC;

Countries

China

Contacts

Public ContactZhou Jundong

Suzhou Municipal Hospital

zhoujundong330@163.com+86 18962174389

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026