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To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer
Patients with pathologically confirmed locally advanced cervical cancer will be treated with concurrent chemoradiotherapy (weekly Albumin-Bound Paclitaxel and cisplatin), followed by Sintilimab 200mg q3w for 8 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles during radical radiation (EBRT followed by brachytherapy); followed by Sintilimab 200mg Q3W for 8 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin-Bound Paclitaxel, cisplatin, Sintilimab | Drug | with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles during radical radiation; followed by Sintilimab 200mg Q3W for 8 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| progression disease free survival | the time interval from the date of treatment to disease progression, local or distant recurrence. | -2 years |
| safety of Albumin-Bound Paclitaxel/cisplatin based concurrent chemoradiotherapy followed by Sintilimab | the occurrence and grade of side effect from treatment according to the CTCAE 4.0 and NCCN clinical practice guidelines in the evaluation treatment-related toxicity (through the symptoms, physical examination, and also through blood/image/encoscopy examination, such as blood routine, liver and renal function, TSH/T3/T4/ACTH concentration, myocardial enzymes, and EKG, echocardiography, CT, et al). | -1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | the percentage of the participants in the population who have a Complete Response or Partial Response accordingly to RECIST 1.1 | 3 months |
| distant-metastasis free survival |
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Inclusion Criteria:
Age between 18 and 75;
Untreated patients with pathologically proven locally advanced cervical cancer;
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Adequate hematological, renal and hepatic functions:
4.1 Hemoglobin > 8.0 g/dl 4.2 Neutrophils > 2000 cells/μl; Leukocytes > 4 × 109/L 4.3 Platelets > 100 × 109/Lg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT/AST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL
Life expectancy > 6 months
Eligible for concurrent chemoradiotherapy assessed by principle investigator;
No obvious active bleeding;
Written informed consent must be available before study registration.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi hospital | Recruiting | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D002945 | Cisplatin |
| C000632826 | sintilimab |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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single arm
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|
the time interval from the date of treatment to distant recurrence.
| -2 years |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D055585 | Physical Phenomena |