Cervical CancersPhase 2NCT06416696
Toripalimab for High-risk Locally Advanced Cervical Cancer
A Phase 2 study testing Toripalimab in people with Cervical Cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancers
- What is being tested?
- Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 22Show fewer
- 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)
- Alanine transaminase (ALT) and aspartate transaminase (AST) levels ≤3×ULN
- Serum creatinine level ≤1.5×ULN
- Thyroid-stimulating hormone (TSH) level ≤1×ULN (with eligibility also extended to patients with free triiodothyronine [FT3] or free thyroxine [FT4] levels ≤1×ULN).
- For women of childbearing potential not undergoing surgical sterilization, a negative serum pregnancy test (hCG) within 72 hours prior to study randomization is required; breastfeeding must be absent. Additionally, the use of a medically approved contraceptive method is mandatory from the time of informed consent through the study treatment period and for 120 days following the final administration of the trial medication or 180 days after the last chemotherapy/radiotherapy session. Participants must also agree not to donate eggs for reproductive purposes or to freeze/preserve eggs for this use during the aforementioned period.
- Provision of a tumor tissue biopsy specimen is mandatory.
- Informed consent must be obtained with documentation.
- Availability for follow-up assessments.
Who cannot join
- 1. 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.
- 3. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 monoclonal antibodies.
- 4. 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.
- 6. 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.
- 7. Active infectious processes necessitating antimicrobial therapy, including the use of antibacterial, antiviral, or antifungal agents.
- 8. History of immunodeficiency, including HIV seropositivity or other acquired and congenital immunodeficiency disorders.
Show all 16Show fewer
- 9. 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.
- 10. A history of arterial or venous thromboembolic events within the past 6 months.
- 11. Poorly controlled hypertension despite antihypertensive therapy (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg).
- 12. Proteinuria of 2+ or higher and a 24-hour urinary protein excretion exceeding 1.0 g.
- 13. Coagulopathy (INR >2.0, PT >16 seconds), a bleeding diathesis, or concurrent anticoagulation or thrombolytic therapy.
- 14. Bilateral hydronephrosis, unless resolved by unilateral stent placement or percutaneous nephrostomy, or deemed mild and without clinical significance by the investigator.
- 15. 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.
- 18. Administration of live vaccines within 4 weeks preceding the first dose of the trial medication. Inactivated seasonal influenza vaccines are permissible.
- 19. History of substance abuse that has not been successfully managed or presence of psychiatric disorders that may interfere with study participation.
- 20. Any medical, psychiatric, or social conditions deemed by the investigator to potentially impact the subject's ability to provide informed consent, participate fully in the study, or affect the interpretability of the study results.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: Toripalimab Combined With Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk Locally Advanced Cervical Cancer: the Phase II Single-arm TorCH -CC Study
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.
Read the detailed description
Cervical cancer is the most prevalent malignant tumor of the female reproductive system in China, with an estimated 150,700 new cases and 55,700 new deaths annually. Concurrent chemoradiotherapy (CRT) remains the standard treatment for locally advanced cervical cancer (LACC). However, for high-risk LACC (HR-LACC) patients, the 2-year progression-free survival (PFS) rate is only 57%-62%, and the 5-year overall survival (OS) rate is 52%-64%, which are the leading causes of patient mortality. The KEYNOTE-A18 study demonstrated that the combination of pembrolizumab and CRT reduced the progression risk and death risk by 30% and 27%, respectively, for HR-LACC patients. Following this, the FDA approved pembrolizumab in combination with CRT for the treatment of newly diagnosed stages III-IVA cervical cancer in January 2024. Nevertheless, the high cost of pembrolizumab poses a significant barrier for patients in China. Toripalimab, the first domestically approved PD-1 inhibitor in China, has shown good safety and efficacy in previous studies and is more affordable. This phase II, single-arm, open-label study aims to evaluate the efficacy and safety of Toripalimab combined with CRT followed by Toripalimab maintenance therapy in 130 patients with stages III-IVA cervical cancer. The primary endpoint is the 2-year PFS. The study is expected to contribute to the implementation of precision and personalized treatment for HR-LACC in China, with the potential to improve patient survival rates and quality of life.
- Conditions
- Cervical Cancers
- Being tested
- Toripalimab
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called Radiotherapy, Chemotherapy(cisplatin)
- Radiotherapy: Both external beam and brachytherapy, with radiation therapy techniques, target delineation, prescribed doses, and organ-at-risk constraints following established guidelines.
- 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.
- 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.
- The concurrent chemoradiotherapy and immunotherapy phase does not exceed 8 weeks in duration.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
2-year progression-free survival (PFS) rate as assessed by the investigator
Measured: 2 year
Secondary outcomes (4)
short-term efficacy assessment
ORR Duration of efficacy (DoR)
Measured: 30 days (±7 days) and 90 days (±7 days) after the last dose
side effects
Treatment-related Side Effects (TRAEs) and immune-related Side Effects (iRAEs)
Measured: 30 days (±7 days) and 90 days (±7 days) after the last dose
OS
2 years of investigator evaluation -OS and PFS, OS
Measured: 2 years
quality of life assessments
quality of life assessments utilizing the EORTC QLQ-C30 v3.0
Measured: 30 days (±7 days) and 90 days (±7 days) after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start9 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancersStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHUANG ZHENG JIA, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- SHUANGZHENG JIA, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416696
- Sponsor's protocol ID
- TorCH-CC
- Status last verified
- Dec 2025
- First submitted
- 11 May 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Combined With Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk Locally Advanced Cervical Cancer: the Phase II Single-arm TorCH -CC Study
- ClinicalTrials.gov ID
- NCT06416696
- Acronym / sponsor ID
- TorCH-CC
- Conditions
- Cervical Cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cervical cancer is the most prevalent malignant tumor of the female reproductive system in China, with an estimated 150,700 new cases and 55,700 new deaths annually. Concurrent chemoradiotherapy (CRT) remains the standard treatment for locally advanced cervical cancer (LACC). However, for high-risk LACC (HR-LACC) patients, the 2-year progression-free survival (PFS) rate is only 57%-62%, and the 5-year overall survival (OS) rate is 52%-64%, which are the leading causes of patient mortality. The KEYNOTE-A18 study demonstrated that the combination of pembrolizumab and CRT reduced the progression risk and death risk by 30% and 27%, respectively, for HR-LACC patients. Following this, the FDA approved pembrolizumab in combination with CRT for the treatment of newly diagnosed stages III-IVA cervical cancer in January 2024. Nevertheless, the high cost of pembrolizumab poses a significant barrier for patients in China. Toripalimab, the first domestically approved PD-1 inhibitor in China, has shown good safety and efficacy in previous studies and is more affordable. This phase II, single-arm, open-label study aims to evaluate the efficacy and safety of Toripalimab combined with CRT followed by Toripalimab maintenance therapy in 130 patients with stages III-IVA cervical cancer. The primary endpoint is the 2-year PFS. The study is expected to contribute to the implementation of precision and personalized treatment for HR-LACC in China, with the potential to improve patient survival rates and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab combined with Chemoradiotherapy followed by Toripalimab maintenance therapy | Experimental | Drug: ToripalimabToripalimab combined with Chemoradiotherapy followed by Toripalimab maintenance therapy for High-risk Locally Advanced Cervical Cancer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (16 listed)
- 1. 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.
- 3. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 monoclonal antibodies.
- 4. 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.
- 6. 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.
- 7. Active infectious processes necessitating antimicrobial therapy, including the use of antibacterial, antiviral, or antifungal agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToripalimabAlso: Radiotherapy, Chemotherapy(cisplatin)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. | Drug | Toripalimab combined with Chemoradiotherapy followed by Toripalimab maintenance therapy |
Primary outcome
progression-free survival (PFS)
Time frame: 2 year
2-year progression-free survival (PFS) rate as assessed by the investigator
4 secondary outcomes
short-term efficacy assessment
Time frame: 30 days (±7 days) and 90 days (±7 days) after the last dose
side effects
Time frame: 30 days (±7 days) and 90 days (±7 days) after the last dose
OS
Time frame: 2 years
quality of life assessments
Time frame: 30 days (±7 days) and 90 days (±7 days) after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancers
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SHUANGZHENG JIA principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab in people with Cervical Cancers, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.