Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer

NCT07092696 | Recruiting Phase 2

• 1 other identifier: E20250419
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the efficacy and tolerability of a platinum-based regimen combined with the PD-1 antibody toripalimab administered prior to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1

  1 year

Secondary Outcomes (2)

• Disease Free Survival

  3 year

• Overall survival

  3 year

Study Arms (1)

PD-1 arm

EXPERIMENTAL

Induction PD-1 inhibitor followed by PD-1 maintenance administered concurrently with chemoradiotherapy and continued after completion.

Drug: Toripalimab; Radiation: Pelvic External-Beam Radiotherapy (EBRT)

Interventions

Toripalimab DRUG

Induction chemo-immunotherapy (platinum-based tri-weekly regimen) * Paclitaxel 175 mg/m² IV on day 1 * Cisplatin 50 mg/m² IV on day 1 or carboplatin AUC 4-5 IV on day 1 * Toripalimab 240 mg IV on day 1, administered immediately before each chemotherapy infusion Cycle length: every 3 weeks Number of cycles: 2 Concurrent chemoradiotherapy (weekly regimen) * Radiation therapy delivered according to institutional protocol * Cisplatin 40 mg/m² IV once weekly * Toripalimab 240 mg IV on day 1 of every 3-week cycle, given before chemotherapy Cycle length: every 3 weeks during radiotherapy Maintenance immunotherapy • Toripalimab 240 mg IV on day 1 every 3 weeks (Q3W) Duration: 1 year (total 13 cycles)

PD-1 arm

Pelvic External-Beam Radiotherapy (EBRT) RADIATION

* PTV: 6 MV photons, 1.80 Gy per fraction × 28 fractions = 50.4 Gy. * PGTVnd: 6 MV photons, 2.14 Gy per fraction × 28 fractions = 59.92 Gy. Brachytherapy:Dose prescriptions * Dose: 7.00 Gy per fraction × 4 fractions = 28.0 Gy.

PD-1 arm

Eligibility Criteria

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

You may qualify if:

• Women aged 18-75 years.
• Histologically confirmed, previously untreated locally advanced cervical cancer of squamous, adenocarcinoma, or adenosquamous type.
• At least one measurable lesion that has not received prior local therapy (non-nodal lesion ≥ 10 mm longest diameter or pathological lymph node ≥ 15 mm short axis, per RECIST 1.1).
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Estimated life expectancy ≥ 6 months.
• Investigator-assessed eligibility for concurrent chemoradiotherapy.
• No clinically significant active bleeding.
• Laboratory values: WBC \> 4 × 10⁹/L; platelets \> 100 × 10⁹/L.
• No history of other malignancies.
• Women of child-bearing potential must have a negative serum pregnancy test and use effective contraception throughout the study.
• Written informed consent obtained prior to any study-related procedures.

You may not qualify if:

• Tumor recurrence or distant metastasis at screening.
• Active autoimmune disease requiring systemic therapy, or any chronic condition requiring long-term high-dose corticosteroids (≥10 mg/day prednisone or equivalent) or other immunosuppressive agents.
• Systemic corticosteroids (\>10 mg/day prednisone or equivalent) or any other immunosuppressive drugs within 14 days before first study dose or anticipated during the study.
• Live-attenuated vaccination within 30 days before first dose or planned during the study.
• Prior organ transplantation or known HIV infection.
• Active hepatitis B (HBV DNA \>2000 IU/mL or \>10⁴ copies/mL, or HBsAg positive) or active hepatitis C (HCV RNA \>10³ copies/mL); co-infection with both viruses is also excluded.
• Prior therapy with any agent targeting PD-1, PD-L1, PD-L2, CD137, CTLA-4 (e.g., ipilimumab), or any other antibody or drug that modulates T-cell co-stimulation or checkpoint pathways.
• Known hypersensitivity to monoclonal antibodies, fusion proteins, or any excipients in the investigational products.
• History of another malignancy within the past 5 years, except adequately treated cervical carcinoma in situ, basal-cell carcinoma of the skin, or other localized malignancies considered cured.
• Severe non-surgical comorbidity or acute infection.
• Peripheral neuropathy \> Grade 1 (NCI-CTCAE).
• Inadequate hematologic or organ function:
• WBC \< 4.0 × 10⁹/L, ANC \< 1.5 × 10⁹/L, platelets \< 100 × 10⁹/L, Hb \< 90 g/L
• TBIL \> 1.5 × ULN, ALT/AST \> 2.5 × ULN, BUN \> 1.5 × ULN, creatinine \> 1.5 × ULN
• Symptomatic brain metastases.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute&Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

toripalimab

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

Central Study Contacts

Jie Chen

CONTACT

+86-18622221202; tjcjvip@126.com

Yuanjie Cao

CONTACT

+86-18522123151; cyjro325@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 30, 2025
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)