Evidence map›Paper›PMID 39762418›Full record

Trial reportNature medicine2025

Neoadjuvant chemoradiation with or without PD-1 blockade in locally advanced rectal cancer: a randomized phase 2 trial.

Yingchi Yang, Kai Pang, Guole Lin, Xinzhi Liu, Jiale Gao, Jiaolin Zhou, Lai Xu, Zhidong Gao, Yingchao Wu, Ang Li and 13 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 28 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05245474 phase2recruitingnot on this map

Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)

TypeinterventionalSponsorBeijing Friendship HospitalRan2022 to 2029Enrolled186ConditionsLocally Advanced Rectal CancerArmsLong-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)
NCT07397442 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Prospective, Phase II, Single-Arm Study on the Efficacy and Safety of Neoadjuvant Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer

TypeinterventionalSponsorBeijing Friendship HospitalRan2026 to 2033Enrolled19ConditionsRectal Cancer, Adenocarcinoma, Rectal Cancer Stage II, Rectal Cancer Stage IIIArmsShort-Course Radiotherapy Combined with Chemotherapy and Immunotherapy
NCT07521605 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Short-Course Radiotherapy Followed by Liposomal Irinotecan, Capecitabine, and Camrelizumab as Neoadjuvant Therapy for Locally Advanced pMMR/MSS Low Rectal Cancer: A Prospective Single-Arm Phase II Trial Protocol

TypeinterventionalSponsorGuangdong Provincial People's HospitalRan2026 to 2034Enrolled44ConditionsRectal Cancer PatientsArmsShort-Course Radiotherapy, Liposomal Irinotecan (nal-IRI), Capecitabine, Camrelizumab
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
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  10. Total neoadjuvant therapy for rectal cancer: where are we now, where do we go?Clinical and translational radiation oncology · 2026
    Review
  11. Review
  12. Review
  13. B cells in cancer: functions, mechanisms and therapeutic advances.Signal transduction and targeted therapy · 2026
    Review
  14. Review
  15. Review
  16. Article
  17. [Current status and future perspectives of precision treatment for locally advanced rectal cancer].Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences · 2026
    Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Yingchi Yang *Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China.ORCID http://orcid.org/0000-0002-9126-3281
Kai Pang *Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China.ORCID http://orcid.org/0009-0001-1945-2870
Guole Lin *Department of General Surgery, Peking Union Medical College Hospital, Beijing, China.ORCID http://orcid.org/0000-0001-6225-3028
Xinzhi Liu *Gastrointestinal Cancer Center, Unit III, Peking University Cancer Hospital and Institute, Beijing, China.
Jiale Gao *Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Jiaolin ZhouDepartment of General Surgery, Peking Union Medical College Hospital, Beijing, China.ORCID http://orcid.org/0000-0003-2020-5161
Lai XuDepartment of General Surgery, Peking Union Medical College Hospital, Beijing, China.
Zhidong GaoDepartment of Gastroenterological Surgery, Peking University People's Hospital, Beijing, China.
Yingchao WuDepartment of General Surgery, Peking University First Hospital, Beijing, China.
Ang LiDepartment of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
Jiagang HanDepartment of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
Guoju WuDepartment of General Surgery, Beijing Hospital, Beijing, China.
Xin WangDepartment of General Surgery, Peking University First Hospital, Beijing, China.
Fei LiDepartment of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
Yingjiang YeDepartment of Gastroenterological Surgery, Peking University People's Hospital, Beijing, China.
Jie ZhangDepartment of Radiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Guangyong ChenDepartment of Pathology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Hao WangClinical Epidemiology and EBM Unit, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Yuanyuan KongClinical Epidemiology and EBM Unit, Beijing Friendship Hospital, Capital Medical University, Beijing, China.ORCID http://orcid.org/0000-0002-2586-1443
Aiwen WuGastrointestinal Cancer Center, Unit III, Peking University Cancer Hospital and Institute, Beijing, China. wuaw@sina.com.ORCID http://orcid.org/0000-0003-3365-3481
Yi XiaoDepartment of General Surgery, Peking Union Medical College Hospital, Beijing, China. xiaoy@pumch.cn.ORCID http://orcid.org/0000-0002-4309-1227
Hongwei YaoDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China. yaohongwei@ccmu.edu.cn.ORCID http://orcid.org/0000-0003-3995-6520
Zhongtao ZhangDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, China. zhangzht@ccmu.edu.cn.ORCID http://orcid.org/0000-0002-4718-6821

Funding

Beijing Postdoctoral Research Foundation 2023-ZZ-038
6 · The paper itself

Abstract

Radiotherapy displays unique antitumor synergism with immune checkpoint inhibitors, which is indicated by high pathological complete response (pCR) rates from single-arm trials of locally advanced rectal cancer (LARC). Here we test the efficacy and safety of the radiation-immune checkpoint inhibitor combination in patients with LARC in a phase 2, randomized trial conducted in eight major colorectal cancer centers in Beijing. In total, 186 eligible all-comer (proficient mismatch repair and deficient mismatch repair) participants were enrolled. The patients were randomly assigned to receive neoadjuvant chemoradiation + concurrent/sequential PD-1 blockade (experiment groups A/B) or neoadjuvant chemoradiation alone (control group). Radical surgeries were scheduled after neoadjuvant treatments. The primary endpoint was the pCR rate. The pCR rates were 27.1%, 32.7% and 14.0% for experiment groups A and B and the control group, respectively. The difference in pCR rates between experiment group B and the control group reached statistical significance (risk ratio 2.332, 95% confidence interval 1.106-4.916; P = 0.019). No substantial differences between either one of the experiment groups and the control group were observed regarding adverse reaction, surgical complication and disease progression. Our results show that adding PD-1 blockade after neoadjuvant chemoradiation increases the pCR rate for patients with LARC and raises no substantial safety concerns. Phase 3 trials with larger sample sizes are warranted (ClinicalTrials.gov identifier NCT05245474 ).

Indexed as

ChemoradiotherapyImmune Checkpoint InhibitorsNeoadjuvant TherapyProgrammed Cell Death 1 ReceptorRectal NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 Receptor

Identifiers

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.