Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R)

Recruiting Phase 2 Interventional Study
Locally Recurrent Rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
Fudan University · Other
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About This Trial
This is an open-label, single arm, phase 2 study. The study is to evaluate the activity of combination therapy of hypofractionated radiotherapy, Irinotecan Hydrochloride Liposome plus 5-FU and leucovorin (NALIRIF), Anti-PD1 and target therapy in patients with locally recurrent rectal cancer (LRRC). The inclusion LRRC patients were failed to oxaliplatin treatment in prior chemotherapy or chemoradio…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Patient is 18-75 years old at the time of signing the informed consent form. ECOG performance status 0-1. MRI/enhanced CT confirmed pelvic recurrence. According to RECIST 1.1, there is at least one measurable pelvic lesion. Distant metastasis lesions are no more than 5 and meta…
Contacts

Zhen Zhang, MD, PhD

18801735029

zhen_zhang@fudan.edu.cn

CONTACT