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Recruiting NCT06391190

Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer

Phase I / Phase II Interventional Locally Advanced Cervical Carcinoma Concurrent Chemoradiotherapy Immunotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Albumin-Bound Paclitaxel, cisplatin, Sintilimab.
Who it may be relevant to
Registry conditions: Locally Advanced Cervical Carcinoma, Concurrent Chemoradiotherapy, Immunotherapy. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Single Arm Trial of Concurrent Chemoradiotherapy (With Albumin-Bound Paclitaxel/Cisplatin) Followed by PD-1 Inhibitor in Locally Advanced Cervical Cancer

Overview

To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer

Detailed description

Patients with pathologically confirmed locally advanced cervical cancer will be treated with concurrent chemoradiotherapy (weekly Albumin-Bound Paclitaxel and cisplatin), followed by Sintilimab 200mg q3w for 8 cycles.

Interventions

  • Drug Albumin-Bound Paclitaxel, cisplatin, Sintilimab
    with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles during radical radiation; followed by Sintilimab 200mg Q3W for 8 cycles

Primary outcome measures

  • progression disease free survival [Time frame: -2 years]
  • safety of Albumin-Bound Paclitaxel/cisplatin based concurrent chemoradiotherapy followed by Sintilimab [Time frame: -1 years]
Secondary outcome measures (2)
  • Objective Response Rate (ORR) [Time frame: 3 months]
  • distant-metastasis free survival [Time frame: -2 years]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 75;
  • Untreated patients with pathologically proven locally advanced cervical cancer;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Adequate hematological, renal and hepatic functions:

4.1 Hemoglobin > 8.0 g/dl 4.2 Neutrophils > 2000 cells/μl; Leukocytes > 4 × 109/L 4.3 Platelets > 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL

  • Life expectancy > 6 months
  • Eligible for concurrent chemoradiotherapy assessed by principle investigator;
  • No obvious active bleeding;
  • Written informed consent must be available before study registration.

Exclusion criteria

  • Recurrent or distant metastatic disease;
  • Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
  • Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
  • Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
  • Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
  • Previous organ transplantation or HIV patients;
  • Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
  • Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA> 103 copies/ml.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • RenJi hospital — Shanghai

Identifiers

NCT: NCT06391190 · ACCI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗