A Phase 1/2 interventional study of PD-1 antibody in Cervical Cancer, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-29.
Sponsored by Peking University Third Hospital · Phase 1/2, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.)
PD-1 antibody combined CCRT for patients with local advanced cervical cancer.
Drug: PD-1 antibody
a new treatment drug combined radical radiotherapy concurrent chemotharpy
Also known as: Toripalimab
Incidence and severity of acute adverse events
safety evaluation
Time frame: up to 3 months complete treatment
Objective response rate
efficacy evaluation
Time frame: 3 months later after treatment
Progression-free survival
efficacy evaluation
Time frame: up to 2 years
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Peking University Third Hospital