Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Fluorouracil

Antibodies

Immunoglobulins

Mitomycins

Mitomycin

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil, and IMRT, followed by adjuvant sintilimab

Concurrent mytomicin C and 5-fluorouracil combined with IMRT

Two cycles of concurrent PD-1 antibody sintilimab combined with mytomicin C, 5-fluorouracil and IMRT, followed by adjuvant sintilimab for six months

PD-1 inhibitor

Two cycles of concurrent mytomicin C and 5-fluorouracil combined with IMRT

concurrent chemoradiotherapy

Xiang-bo Wan, PhD

Fang He, MD

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).

Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients

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

acute toxicities according to the NCI CTCAE (version 4.0)

The rate of late toxicity according to the RTOG/EORTC scale

Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events

Sixth Affiliated Hospital, Sun Yat-sen University

Docetaxel

Cisplatin

Neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and concurrent toripalimab

Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.

Toripalimab

Locally Advanced Anal Canal Squamous Carcinoma Patients will be enrolled and given four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab. Treatment outcomes and toxicities will be evaluated.

PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients

Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients

Study data can be shared after publication of the study results, upon request.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chemoradiotherapy Combined With or Without PD-1 Blockade in Anal Canal Squamous Carcinoma Patients	NCT05374252	Anal Canal Canc... Anal Squamous C... Anal Canal Canc... Anal Cancer	PD-1 inhibitor concurrent chem...	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients	NCT05060471	Anal Canal Canc... Anal Squamous C... Anal Cancer Anal Canal Canc... Anal Canal Canc... Anal Canal Canc...	Toripalimab	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for anal canal cancer stage iii