NCT04411537 is a Phase 2 clinical trial of PD-1 antibody in Locally Advanced Rectal Cancer, sponsored by Fudan University.

Who is sponsoring NCT04411537?

NCT04411537 is sponsored by Fudan University.

What drugs are being tested in NCT04411537?

Interventions in NCT04411537: PD-1 antibody, Capecitabine, Irinotecan, Neoadjuvant Radiotherapy.

What condition does NCT04411537 study?

NCT04411537 studies Locally Advanced Rectal Cancer.

Is NCT04411537 still recruiting?

NCT04411537 is currently status unknown. Last updated 2 June 2020.

Last reviewed 2020-06-02 · How we verify

NCT04411537

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer

Status unknown Phase 2 Last updated 2 June 2020

What this trial tests

Phase 2 trial testing PD-1 antibody in Locally Advanced Rectal Cancer in 50 participants. Status unknown.

Timeline

1 July 2020

Primary endpoint
30 April 2022

31 December 2022

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 July 2020
Primary completion	30 April 2022
Estimated completion	31 December 2022
Sites	1 location across China

Drugs / interventions tested

PD-1 antibody — full drug profile →
Capecitabine (capecitabine) — full drug profile →
Irinotecan (irinotecan) — full drug profile →
Neoadjuvant Radiotherapy

Conditions studied

Locally Advanced Rectal Cancer — all drugs for Locally Advanced Rectal Cancer →

Sponsor

Fudan University

Who can join

Adults 18 to 70, any sex, with Locally Advanced Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stable (MSS) locally advanced rectal cancer (LARC). A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Immune Checkpoint Inhibitors in pMMR Metastatic Colorectal Cancer: A Tough Challenge.
Marmorino F, Boccaccino A, Germani MM, Falcone A, et al · · 2020 · cited 39× · PMID 32824490 · DOI 10.3390/cancers12082317
Neoadjuvant immunotherapy for colorectal cancer: Right regimens, right patients, right directions?
Zhu J, Lian J, Xu B, Pang X, et al · · 2023 · cited 38× · PMID 36949951 · DOI 10.3389/fimmu.2023.1120684
Emerging Trends for Radio-Immunotherapy in Rectal Cancer.
Corrò C, Dutoit V, Koessler T. · · 2021 · cited 24× · PMID 33803620 · DOI 10.3390/cancers13061374
Clinical trials of neoadjuvant immune checkpoint inhibitors for early-stage operable colon and rectal cancer.
Veen T, Kanani A, Lea D, Søreide K. · · 2023 · cited 21× · PMID 37528319 · DOI 10.1007/s00262-023-03480-w
Harnessing the abscopal effect for gastrointestinal malignancies in the era of immunotherapy.
Hino C, Lee EW, Yang GY. · · 2023 · cited 4× · PMID 37435204 · DOI 10.21037/jgo-23-105

Verify or expand the search:

Other trials of PD-1 antibody

Trials testing the same drug.

NCT07403136 — Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC · Phase 2 · suspended
NCT07318636 — NK-cell Therapy Combined With PD-1 Antibody and Platinum-Based Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC · Phase 1 · not yet recruiting
NCT07472153 — PD-1 (Programmed Death-1) Versus PD-L1 (Programmed Death-ligand 1) Immune Check Point Inhibitors Combined With Chemother · Phase 2, PHASE3 · recruiting
NCT06928584 — Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer · Phase 2 · recruiting
NCT06840665 — MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer · Phase 2 · recruiting

Other recruiting trials for Locally Advanced Rectal Cancer

Currently open trials in the same condition.

NCT07527026 — A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant T · Phase 2 · recruiting
NCT07514754 — Galenos 2 Immunonutrition in Head and Neck, Lung, and Rectal Cancer Patients · NA · recruiting
NCT07150949 — Long-course Chemoradiotherapy or Short-course Radiotherapy Combined With CAPOX, PD-1antibody, and COX-2 Inhibitor for MS · Phase 2 · recruiting
NCT07057089 — Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I) · Phase 2 · recruiting
NCT06894797 — Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer. · NA · recruiting

Other Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04411537 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fudan University
Last refreshed: 2 June 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04411537.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing