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

NCT06391190 | Recruiting Phase 1 DMC

• 1 other identifier: ACCI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Locally Advanced Cervical Carcinoma; Concurrent Chemoradiotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• progression disease free survival

  the time interval from the date of treatment to disease progression, local or distant recurrence.

  -2 years

• safety of Albumin-Bound Paclitaxel/cisplatin based concurrent chemoradiotherapy followed by Sintilimab

  the occurrence and grade of side effect from treatment according to the CTCAE 4.0 and NCCN clinical practice guidelines in the evaluation treatment-related toxicity (through the symptoms, physical examination, and also through blood/image/encoscopy examination, such as blood routine, liver and renal function, TSH/T3/T4/ACTH concentration, myocardial enzymes, and EKG, echocardiography, CT, et al).

  -1 years

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  3 months

• distant-metastasis free survival

  -2 years

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Drug: Albumin-Bound Paclitaxel, cisplatin, Sintilimab

Interventions

Albumin-Bound Paclitaxel, cisplatin, Sintilimab DRUG

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

Also known as: radiation

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

RenJi hospital

Shanghai, 200127, China

RECRUITING

MeSH Terms

Interventions

Albumin-Bound Paclitaxel; Cisplatin; sintilimab; Radiation

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single arm

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: January 1, 2022
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)