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To evaluate the safety and efficacy of anti-PD-1 (toripalimab) combined with cisplatin concurrent IMRT for locally advanced cervical cancer.
The dose of toripalimab injection (pd-1 antibody) was 240mg/d, d1, i.v. every 14d, totally 4 cycles (56 days)
Concurrent chemoradiotherapy:
Cisplatin 40 mg/m2 i.v., d1, administered once a week; Radiotherapy: pelvic intensity modulated radiotherapy, prescription dose DT: 50.4gy /2Gy/28f;After intraluminal irradiation DT: 30-36 Gy/6Gy/5-6f 2f/w, complete the radiotherapy within 56 days.
Complete at least 4 cycles of concurrent chemoradiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | PD-1 antibody combined CCRT for patients with local advanced cervical cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-1 antibody | Drug | a new treatment drug combined radical radiotherapy concurrent chemotharpy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of acute adverse events | safety evaluation | up to 3 months complete treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | efficacy evaluation | 3 months later after treatment |
| Progression-free survival | efficacy evaluation | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Patients with previous PD-1 or PD-L1 treatment
Patients with previous abdominal or pelvic radiotherapy
Other malignant tumors other than cervical cancer appeared in the past 5 years
Immunosuppressive drugs were used within 4 weeks prior to the first study treatment, excluding nasal spray, inhaled or other local glucocorticoids or systemic glucocorticoids in physiological doses (i.e., no more than 10 mg/ day prednisone or equivalent doses of other glucocorticoids)
Active, known, or suspected autoimmune disease (congenital or acquired)
), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroiditis, etc. (vitiligo or childhood asthma has been completely relieved, adults without any intervention can be included;Patients with type 1 diabetes with good insulin control can also be enrolled, as can hypothyroidism caused by autoimmune thyroiditis that requires hormone replacement therapy.)
Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
Known allergy to any component of the drug
Serious medical diseases that are not under control, such as the combination of serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension,uncontrolled infection, active peptic ulcer
Received other experimental drugs or participated in other drugs within 30 days of initial administration clinical research on the purpose of anticancer therapy
Severe infection occurred within 4 weeks prior to study treatment, including, but not limited to, hospitalization hospital treatment of infection complications, bacteremia or severe pneumonia
Human immunodeficiency virus (HIV) positive
Hepatitis B surface antigen (HBsAg) positive, and the peripheral blood hepatitis B virus deoxygenation the titer of ribonucleic acid (HBV-DNA) was detected in subjects ≥1×10<3> IU/mL
Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) Antibody positive and HCV RNA positive
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Jiang, MD | Contact | 010-82266699 | 4912 | drjiangping@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Junjie Wang, MD | Peking University 3rd Hospital radiation oncology department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University 3rd Hospital | Beijing | Beijng | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41087995 | Derived | Jiang P, Wei S, Li C, Qu A, Chen H, Zhang H, Guo H, Wang J. Safety and efficacy of toripalimab plus concurrent chemoradiotherapy for locally advanced cervical cancer: a single-arm, phase Ib trial. BMC Cancer. 2025 Oct 14;25(1):1566. doi: 10.1186/s12885-025-15059-y. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| C000656314 | toripalimab |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |