Evidence map›Paper›PMID 40673011›Full record

ArticleEClinicalMedicine2025

Total neoadjuvant therapy integrating long-course radiotherapy with trifluridine/tipiracil for locally advanced rectal cancer: a single-arm, multicenter phase 2 trial.

Xue Dou, Lina Zhao, Zhenyu Ma, Lichun Wei, Xin Jiang, Yi Ding, Shichang Sun, Yanlai Sun, Minghuan Li, Rui Feng and 9 more

Abstract read
In one paragraph

Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

19 authors.

Xue DouDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Lina ZhaoDepartment of Radiation Oncology, Xijing Hospital, Air Force Medical University, Xi'an, China.
Zhenyu MaDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Lichun WeiDepartment of Radiation Oncology, Xijing Hospital, Air Force Medical University, Xi'an, China.
Xin JiangDepartment of Radiation Oncology & Therapy, The First Hospital of Jilin University, Changchun, China.
Yi DingDepartment of Radiation Oncology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Shichang SunDepartment of Radiation Oncology, Jining Cancer Hospital, Jining, China.
Yanlai SunDepartment of Colorectal Cancer Surgery, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Minghuan LiDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Rui FengDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Kunli ZhuDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Fang ShiDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Kai LiuDepartment of Colorectal Cancer Surgery, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Minghao LiDepartment of Radiotherapy, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Yongsheng GaoDepartment of Pathology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Peng SuDepartment of Pathology, Qilu Hospital of Shandong University, Jinan, China.
Shanshan LiDepartment of Radiology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Jinming YuDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Jinbo YueDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Total neoadjuvant therapy (TNT) is recommended for locally advanced rectal cancer (LARC) with high-risk factors. The objective of this multi-center phase 2 study is to evaluate the impact of a newly designed TNT consist of TAS-102 concurrent with long-course radiotherapy followed by consolidative TAS-102 and oxaliplatin on the pathological complete response (pCR) rate in patients with LARC. Methods: Patients with LARC were to receive a newly designed TNT consisting of radiotherapy (50 Gy/25 fractions) concurrently with oral TAS-102 (35 mg/m Findings: From September 1, 2022 through January 11, 2024, 50 patients were enrolled and treated; 44 (88%) received surgery. Among all 50 patients, the overall complete response rate (pCR and clinical complete response [cCR]) was 32% (95% confidence interval [CI] 20-47). Among the 44 patients who underwent surgery, the pCR rate was 32% (95% CI 19-48), exceeding the hypothesized standard pCR rate of 13%. The major pathological regression rate was 52% (95% CI 37-68), and the pathological complete lymph node regression rate was 61% (95% CI 45-76). Of the 6 patients who did not receive surgery, 2 achieved cCR followed by observation, 1 was confirmed to have high microsatellite instability and refused surgery, and 3 refused surgery for personal reasons. Grade 3 hematologic toxicity was recorded in 10 patients (20%) and grade 4 in 3 (6%), consisting largely of myelosuppression. Most patients had mild gastrointestinal toxicity; the most common grade 3 and 4 toxicity was diarrhea (14%). No patients had hand-foot skin reactions. Interpretation: We found that TAS-102 concurrent with preoperative radiotherapy led to a high pCR rate (32%) with acceptable toxicity among patients with stage Ⅱ/Ⅲ rectal cancer. Prospective randomized controlled trials comparing fluoropyrimidine-based and TAS-102-based TNT are warranted. Funding: National Natural Science Foundation of China and Shandong Provincial Natural Science Foundation.

Indexed as

Locally advanced rectal cancerLong-course radiotherapyPathological complete responseTotal neoadjuvant therapyTrifluridine/tipiracil

Identifiers

PMID40673011
PMCPMC12264633

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Registered trials

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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.