Toripalimab for High-risk Locally Advanced Cervical Cancer

NCT06416696 | Active Not Recruiting Phase 2

• 1 other identifier: TorCH-CC
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II clinical study assesses the efficacy and safety of Toripalimab combined with chemoradiotherapy (CRT) followed by Toripalimab maintenance in treating high-risk locally advanced cervical cancer (HR-LACC). Despite CRT being the standard treatment, HR-LACC patients face poor survival outcomes. Toripalimab, a cost-effective PD-1 inhibitor, has shown promise in prior research. The primary endpoint is 2-year progression-free survival, with the study aiming to improve treatment accessibility and patient prognoses in China.

Conditions

Cervical Cancers

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  2-year progression-free survival (PFS) rate as assessed by the investigator

  2 year

Secondary Outcomes (4)

• short-term efficacy assessment

  30 days (±7 days) and 90 days (±7 days) after the last dose

• side effects

  30 days (±7 days) and 90 days (±7 days) after the last dose

• OS

  2 years

• quality of life assessments

  30 days (±7 days) and 90 days (±7 days) after the last dose

Study Arms (1)

Toripalimab combined with Chemoradiotherapy followed by Toripalimab maintenance therapy

EXPERIMENTAL

Toripalimab combined with Chemoradiotherapy followed by Toripalimab maintenance therapy for High-risk Locally Advanced Cervical Cancer

Drug: Toripalimab

Interventions

Toripalimab DRUG

1. Radiotherapy: Both external beam and brachytherapy, with radiation therapy techniques, target delineation, prescribed doses, and organ-at-risk constraints following established guidelines. 2. Chemotherapy: The preferred regimen is cisplatin at a dose of 40mg/m\^2 administered intravenously once weekly for 5-6 cycles; for patients intolerant to cisplatin or with renal impairment, carboplatin (AUC=2) may be considered, also administered once weekly. 3. Toripalimab concurrent immunotherapy: Following the regimens of phase III RCTs such as JUPITER-02, JUPITER-06, CHOICE-01, NEOTORCH, and RENOTORCH, Toripalimab is administered at a fixed dose of 240mg per infusion, given intravenously once every 3 weeks for three doses. 4. The concurrent chemoradiotherapy and immunotherapy phase does not exceed 8 weeks in duration.

Also known as: Radiotherapy, Chemotherapy(cisplatin)

Toripalimab combined with Chemoradiotherapy followed by Toripalimab maintenance therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
• FIGO 2018 staging criteria classifying the disease as stages III-IVA.
• Age range from 18 to 70 years inclusive.
• No prior receipt of surgery, radiotherapy, or systemic anticancer therapy for the treatment of cervical cancer.
• No previous exposure to the study drug.
• Presence of at least one measurable or evaluable lesion as per RECIST version 1.1, with the measurable lesion exhibiting a longest diameter of ≥10 mm on spiral CT scan or a shortest diameter of ≥15 mm for enlarged lymph nodes, which has not been previously irradiated.
• Absence of central nervous system diseases, both primary and metastatic.
• WHO/ECOG performance status score of 0-1.
• Anticipated survival duration of at least 12 weeks.
• Adequate organ function within the following parameters (without the use of any blood components, cytokines, or growth factors within 14 days prior to randomization):
• Absolute neutrophil count (ANC) ≥1.5×10\^9/L
• Platelet count ≥90×10\^9/L
• Hemoglobin level ≥90 g/L
• Serum albumin level ≥30 g/L
• Bilirubin level ≤1.5 times the upper limit of normal (ULN)

You may not qualify if:

• \. Known hypersensitivity to any component of the study medication. 2. Participation in other clinical trials, with a washout period of less than 4 weeks following completion.
• \. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 monoclonal antibodies.
• \. Patients requiring immunosuppressive pharmacotherapy. 5. Individuals requiring systemic or absorbable topical corticosteroids at immunosuppressive doses. Use of prednisone at a dosage greater than 10mg/day or equivalent is prohibited within two weeks of study drug administration.
• \. Presence of active autoimmune diseases or a history thereof, excluding vitiligo, resolved childhood asthma, or resolved atopic diseases. Patients with asthma requiring intermittent bronchodilator therapy or other interventions are also excluded.
• \. Active infectious processes necessitating antimicrobial therapy, including the use of antibacterial, antiviral, or antifungal agents.
• \. History of immunodeficiency, including HIV seropositivity or other acquired and congenital immunodeficiency disorders.
• \. Uncontrolled cardiac symptoms or diseases, such as NYHA class II or higher heart failure, unstable angina, myocardial infarction within the past year, atrial fibrillation, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, PR interval greater than 250 ms, or QTc interval ≥470 ms.
• \. A history of arterial or venous thromboembolic events within the past 6 months.
• \. Poorly controlled hypertension despite antihypertensive therapy (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg).
• \. Proteinuria of 2+ or higher and a 24-hour urinary protein excretion exceeding 1.0 g.
• \. Coagulopathy (INR \>2.0, PT \>16 seconds), a bleeding diathesis, or concurrent anticoagulation or thrombolytic therapy.
• \. Bilateral hydronephrosis, unless resolved by unilateral stent placement or percutaneous nephrostomy, or deemed mild and without clinical significance by the investigator.
• \. Contraindications to chemotherapy administration. 16. Contraindications to receiving brachytherapy. 17. History of other malignancies within the past 5 years, except for basal cell carcinoma and squamous cell carcinoma of the skin.
• \. Administration of live vaccines within 4 weeks preceding the first dose of the trial medication. Inactivated seasonal influenza vaccines are permissible.
• \. History of substance abuse that has not been successfully managed or presence of psychiatric disorders that may interfere with study participation.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

toripalimab; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• SHUANGZHENG JIA

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: January 9, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)