Tests toripalimab with chemotherapy and radiation for advanced cervical cancer
Tests immunotherapy with chemotherapy before radiation in adults with advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18-75 with locally advanced cervical cancer who have not been treated before and can have chemoradiotherapy. It tests toripalimab with chemotherapy before chemoradiotherapy.
- Age
- 18-75 years
- Sex
- Women only
- Disease stage
- Locally advanced cervical cancer (squamous, adenocarcinoma or adenosquamous type), confirmed by biopsy, with at least one measurable tumour lesion that has had no local treatment. ECOG performance status 0-1.
- Earlier treatment
- No earlier treatment for the cervical cancer. No earlier treatment with PD-1, PD-L1, PD-L2, CD137 or CTLA-4 drugs.
Main reasons for not taking part
- Cancer has come back or spread to distant organs
- Active autoimmune disease or ongoing treatment that weakens the immune system
- Organ transplant in the past or known HIV infection
- Active hepatitis B or hepatitis C
- Pregnant or breastfeeding
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07092696, who can take part
Where in China
- Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Medical University Cancer Institute and Hospital
- Trial code
- NCT07092696
- Record updated
- 30 July 2025
- Original description
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.Read full original descriptionShow less
Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial
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.
Inclusion: 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.
Exclusion: 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; Clinically significant cardiac arrhythmias, myocardial ischemia, severe conduction block, heart failure, or severe valvular disease; Severe bone-marrow failure; Uncontrolled psychiatric illness; Pregnant or lactating women; Investigator-judged unsuitability for the trial; Concurrent participation in another interventional clinical study.