NCT05245474

Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

Recruiting now Phase 2 Last updated 10 January 2024

What this trial tests

Phase 2 trial testing Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor) in Locally Advanced Rectal Cancer in 186 participants. Currently enrolling.

Timeline

1 April 2022

Primary endpoint
1 March 2024

1 September 2029

Quick facts

Lead sponsor	Beijing Friendship Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	186
Start date	1 April 2022
Primary completion	1 March 2024
Estimated completion	1 September 2029
Sites	8 locations across China

Drugs / interventions tested

• Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)

Conditions studied

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

Sponsor

Beijing Friendship Hospital

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

This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).

Publications & conference data

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

1. Efficacy and safety of PD-1 blockade plus long-course chemoradiotherapy in locally advanced rectal cancer (NECTAR): a multi-center phase 2 study.
   Yang Z, Gao J, Zheng J, Han J, et al · · 2024 · cited 47× · PMID 38462629 · DOI 10.1038/s41392-024-01762-y
2. Neoadjuvant chemoradiation with or without PD-1 blockade in locally advanced rectal cancer: a randomized phase 2 trial.
   Yang Y, Pang K, Lin G, Liu X, et al · · 2025 · cited 20× · PMID 39762418 · DOI 10.1038/s41591-024-03360-5
3. Combination of Immunotherapy and Radiation Therapy in Gastrointestinal Cancers: An Appraisal of the Current Literature and Ongoing Research.
   Kumar R, Kim J, Deek MP, Eskander MF, et al · · 2023 · cited 7× · PMID 37504333 · DOI 10.3390/curroncol30070473
4. Long-course chemoradiation plus concurrent/sequential PD-1 blockade as neoadjuvant treatment for MMR-status-unscreened locally advanced rectal cancer: protocol of a multicentre, phase 2, randomised controlled trial (the POLAR-STAR trial).
   Pang K, Pang K, Yang Y, Tian D, et al · · 2023 · cited 6× · PMID 37699634 · DOI 10.1136/bmjopen-2022-069499
5. Combination immunotherapy for colorectal cancer: Clinical applications, rationale, challenges, and future perspectives.
   Fei J, Cai C, Wu W, Shen H, et al · · 2026 · PMID 41950929 · DOI 10.1016/j.xcrm.2026.102728
6. Neoadjuvant chemoradiotherapy with or without PD-1 inhibitors in MMR-proficient non-metastatic rectal cancer: a meta-analysis of randomized controlled trials.
   Li Y, Han C, Tang J. · · 2026 · PMID 41853263 · DOI 10.3389/fimmu.2026.1792283
7. Synergistic effects of radiotherapy and immunotherapy: improving oncological outcomes.
   Chen X, Liu W, Wang Y, Yue Z, et al · · 2026 · PMID 41716387 · DOI 10.3389/fimmu.2026.1771355
8. Integrating Immune Checkpoint Inhibitors With Total Neoadjuvant Therapy in Proficient Mismatch Repair Rectal Cancer.
   Kagawa Y, Watanabe J, Ando K, Kitchens C, et al · · 2026 · PMID 41488839 · DOI 10.1002/ags3.70083