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To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.
For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction immunotherapy and chemotherapy | Experimental | Patients enrolled in this arm would receive neoadjuvant immunotherapy and chemotherapy before definitive chemoradiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Patients enrolled in this arm would receive three cycles of induction treatment before receiving definitive chemoradiotherapy. The specific regimen is: Paclitaxel(135mg/m2,ivd, d1)+cisplatin(75mg/m2,ivd,d1-3)+Toripalimab (240mg,ivd,d1)±bevacizumab(ivd, d1)/q21d. Patients would receive pelvic MRI to evaluate the regression status of tumor after three cycles of induction treatment. Patients with satisfying tumor regression would receive definitive chemoradiotherapy afterwards. During chemoradiotherapy, patients would receive weekly cisplatin (40mg/m2) and 240mg toripalimab every three weeks. After chemoradiotherapy, patients would receive another three cycles of consolidated treatment (regimen identical to induction treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Volume changes of core radiation targets and irradiated normal tissues after induction treatment | Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50 | 5-year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from diagnosis of disease to disease progression or death due to any cause | 1-year, 2-year |
| Distant metastasis-free survival | Time from diagnosis to distant metastasis or death due to any cause |
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Inclusion Criteria:
Exclusion Criteria:
Concomitant other malignancies;
Patients with metastatic or recurrent disease;
Patients received any form of treatment before enrollment;
Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;
Impaired hematological, renal or hepatic functions:
g. Serum urea nitrogen (BUN) > 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) > 1.5 × upper normal limit (UNL)
Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
Patients with uncontrolled mental diseases;
Pregnant or lactating woman;
Participating in other clinical trials;
Anyone considered not suitable for enrollment by principal investigator;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanjie Cao | Contact | +86-18522123151 | cyjro325@gmail.com | |
| Chen Li | Contact | +86-15510932601 | lichen.radonco@tmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jie Chen | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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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 |
|---|---|
| C000656314 | toripalimab |
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|
| 1-year, 2-year |
| Incidence of treatment-related side effects | Incidence of treatment-related side effects (i.e., radiation-related proctitis, cystitis, ,vaginitis, etc.) | 5-year |
| 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 |