NCT05374252
Recruiting
Phase 3
A Phase 3, Multicenter, Double-Blind Randomized Study of Mitomycin, 5-Fluorouracil and IMRT Combined With or Without Anti-PD-1 in Patients With Locally Advanced Anal Canal Squamous Carcinoma
Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country102 target enrollmentMay 7, 2022
DrugsPD-1 inhibitor
Overview
- Phase
- Phase 3
- Intervention
- PD-1 inhibitor
- Conditions
- Anal Canal Cancer Stage III
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Progression free survival
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a phase III, multi-center, double-blind randomized controlled trial assessing the efficacy and safety of concurrent mitomycin C/5-Fu chemotherapy and long-course IMRT combined with PD-1 antibody Sintilimab for locally advanced anal canal squamous carcinoma patients, by comparing an experiment group (traditional chemoradiotherapy with PD-1 antibody Sintilimab) with a control group (traditional treatment without Sintilimab).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histology identified anal canal squamous carcinoma,
- •Aged 18 to 75,
- •Clinical staging III, Eastern Cooperative Oncology Group 0-2 score,
- •The Staging method: All patients undergoing rectal anus palpation, high resolution MRI and chest-abdominal enhanced CT, clinical data should be re-evaluated and inclusive by center evaluation group when there is contradictory staging, distant metastasis were excluded by chest-abdominal enhanced CT and pelvic enhanced MRI,
- •No previous anal canal surgery or anal tumor resection (except for biopsy),
- •No previous chemotherapy or pelvic radiotherapy history,
- •No biopharmaceutical treatment history (such as monoclonal antibody), immunotherapy (such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment in the previous 5 years,
- •Adequate bone marrow, liver, and kidney function,
- •Clinical complete response (cCR) (Chest, abdominal and pelvic enhanced CT or pelvic enhanced MRI or PET/CT),
- •Informed consent assigned, Final inclusion criteria,
Exclusion Criteria
- •Diagnosed as stage I-II and well differentiated squamous cell carcinoma,
- •Distant metastasis,
- •Received radiation therapy in abdominal or pelvic regions,
- •Pregnant, lactating woman patient or fertile but lacks adequate contraceptives,
- •Arrhythmia need anti-arrhythmia treatment (except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia (myocardial infarction within 6 months) or congestive heart-failure (CHF) \> New York Heart Association grade II,
- •Severe hypertension not well controlled by drugs,
- •Active phase of chronic hepatitis B or hepatitis C (high copies of virus DNA),
- •Patients with active tuberculosis (TB) are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening,
- •Other active clinical severe infection (NCI-CTCAE (version 4.0) ),
- •Dyscrasia, organ dysfunction,
Arms & Interventions
Experimental Group
Concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil, and IMRT, followed by adjuvant sintilimab
Intervention: PD-1 inhibitor
Control Group
Concurrent mytomicin C and 5-fluorouracil combined with IMRT
Intervention: concurrent chemoradiotherapy
Outcomes
Primary Outcomes
Progression free survival
Time Frame: from the end of treatment to 3 years after treatment
progression free survival
Overall survival
Time Frame: from the end of treatment to 3 years after treatment
overall survival
cCR rate
Time Frame: 6 months after treatment
cCR rate 6 months after treatment
Secondary Outcomes
- Acute toxicities(from the start of treatment to 3 months after treatment)
- Colostomy rate(2 year)
- Local recurrence rate(from the end of treatment to 3 years after treatment)
- Distant metastasis rate(from the end of treatment to 3 years after treatment)
- cCR rate(3 months after treatment)
- The rate of late toxicity according to the RTOG/EORTC scale(3 years)
- Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events(1 year)
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Phase 3
A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell LymphomaNCT06776952Evopoint Biosciences Inc.120
Completed
Phase 3
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque PsoriasisPsoriasisNCT03701763Amgen245
Completed
Phase 3
Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary CirrhosisPBCNCT06715319Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.100
Withdrawn
Phase 3
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP)Primary Immune Thrombocytopenia (ITP)NCT04274452argenx
Completed
Phase 3
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).Primary Immune ThrombocytopeniaNCT04188379argenx131