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

Immunotherapy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391190
• Other study ID #: ACCI
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2022
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 75;

2. Untreated patients with pathologically proven locally advanced cervical cancer;

3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

4. 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

5. Life expectancy > 6 months

6. Eligible for concurrent chemoradiotherapy assessed by principle investigator;

7. No obvious active bleeding;

8. Written informed consent must be available before study registration.

Exclusion Criteria:

1. Recurrent or distant metastatic disease;

2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;

3. Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;

4. 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;

5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;

6. Previous organ transplantation or HIV patients;

7. Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;

8. 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.

Related Conditions & MeSH terms

• Concurrent Chemoradiotherapy
• Immunotherapy
• Locally Advanced Cervical Carcinoma
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	RenJi hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression disease free survival	the time interval from the date of treatment to disease progression, local or distant recurrence.	-2 years
Primary	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	Objective Response Rate (ORR)	the percentage of the participants in the population who have a Complete Response or Partial Response accordingly to RECIST 1.1	3 months
Secondary	distant-metastasis free survival	the time interval from the date of treatment to distant recurrence.	-2 years