NCT06840665 is a Phase 2 clinical trial of PD-1 antibody in Locally Advanced Rectal Cancer, sponsored by Fudan University.

Who is sponsoring NCT06840665?

NCT06840665 is sponsored by Fudan University.

What drugs are being tested in NCT06840665?

Interventions in NCT06840665: PD-1 antibody, Oxaliplatin, Capecitabine.

What condition does NCT06840665 study?

NCT06840665 studies Locally Advanced Rectal Cancer.

Is NCT06840665 still recruiting?

NCT06840665 is currently recruiting now. Last updated 21 February 2025.

Last reviewed 2025-02-21 · How we verify

NCT06840665

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

MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer

Recruiting now Phase 2 Last updated 21 February 2025

What this trial tests

Phase 2 trial testing PD-1 antibody in Locally Advanced Rectal Cancer in 46 participants. Currently enrolling.

Timeline

13 August 2024

Primary endpoint
12 August 2026

12 February 2027

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	13 August 2024
Primary completion	12 August 2026
Estimated completion	12 February 2027
Sites	1 location across China

Drugs / interventions tested

PD-1 antibody — full drug profile →
Oxaliplatin (Oxaliplatin) — full drug profile →
Capecitabine (capecitabine) — full drug profile →

Conditions studied

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

Sponsor

Fudan University

Who can join

Adults 18 to 75, any sex, with Locally Advanced Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

NeoPulsar is a prospective, randomized phase II trial. 46 LARC (T3-4/N+M0, distance from anal verge ≤12cm) patients will be treated with MR-guided adaptive radiotherapy (30Gy/6Fx) combined with 6 cycles of Toripalimab and CAPOX. TME surgery is scheduled after TNT. The primary endpoint is pathological complete response (pCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal function, surgical complication, 3-year LRFS rate, 3-year DFS rate, 3-year OS rate, etc.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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
NCT06507371 — Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer · Phase 3 · 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 NCT06840665 (US National Library of Medicine, public domain)
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: 21 February 2025

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/NCT06840665.

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