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A prospective single arm trial of concurrent chemoradiotherapy (with nab-paclitaxel/cisplatin) followed by PD-1 inhibitor in advanced cervical cancer

A prospective single arm trial of concurrent chemoradiotherapy (with nab-paclitaxel/cisplatin) followed by PD-1 inhibitor in advanced cervical cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055686
Enrollment
Unknown
Registered
2022-01-16
Start date
2022-03-15
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

cervical cancer

Interventions

Experimental group:CCRT followed by PD-1 inhibitor

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old; 2. Able to understand and sign informed consent; 3. Locally advanced cervical cancer confirmed by histology and pathology, the pathological type is squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma, and the FIGO2018 stage is III-IVA stage; 4. ECOG score 0-2 points; 5. LVEF >= 55%; 6. The absolute value of neutrophils >= 1.0 x 10^9/L, lymphocytes >= 1.0 x 10^9/L, platelets >= 80 x 10^9/L, hemoglobin >= 7.0 g/dL, creatinine <= 2 times the upper limit of the normal value, alanine aminotransferase <= 3 times the upper limit of normal value, aspartate aminotransferase <= 3 times the upper limit of normal value, total bilirubin <= 1.5 times the upper limit of normal value; 7. For women who may be pregnant, the blood test or urine test before treatment is negative, and there is a suitable contraceptive method during the treatment cycle.

Exclusion criteria

Exclusion criteria: 1. There is distant metastasis; 2. Previously received nab-paclitaxel treatment; 3. Previously received abdominal or pelvic radiotherapy; 4. Suffering from central nervous system diseases; 5. Suffering from other malignant tumors in the past 5 years; 6. Peripheral neuropathy of grade 2 or above; 7. Serious uncontrollable diseases that prevent patients from receiving treatment normally, for example: serious medical diseases, including serious heart disease and cerebrovascular disease; 8. Diabetes; 9. HBV-DNA or HBsAg positive; 10. HCV or HIV positive; 11. Active or recent autoimmune diseases, or diseases that require systemic hormones or immunosuppressants recently; 12. Autoimmune thyroiditis; 13. Previously received immunotherapy, including tumor vaccines, cytokines, anti-CTLA4, PD-1 inhibitors, PD-L1 inhibitors or similar; 14. The investigator believes that there are other conditions that do not meet the enrollment requirements.

Design outcomes

Primary

MeasureTime frame
2-year progression-free survival rate;

Countries

China

Contacts

Public ContactYongrui Bai

Renji Hospital, Shanghai Jiaotong University School of Medicine

baiyongrui@renji.com+86 13301013916

Outcome results

None listed

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