Evidence map›Paper›PMID 36816939›Full record

ArticleFrontiers in oncology2023

Interim result of phase II, prospective, single-arm trial of long-course chemoradiotherapy combined with concurrent tislelizumab in locally advanced rectal cancer.

Jiale Gao, Xiao Zhang, Zhengyang Yang, Jie Zhang, Zhigang Bai, Wei Deng, Guangyong Chen, Rui Xu, Qi Wei, Yishan Liu and 7 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04911517 (Rationale and Design of a Prospective, Multicenter Phase Ⅱ Clinical Trial of Safety and Efficacy Evaluation of Long Course Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.), which is not on this map. Cited by 18 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 5 pooled it
4.4field-weighted citation impact, top 5% of its field
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.

NCT04911517 phase2unknown statusnot on this map

Rationale and Design of a Prospective, Multicenter Phase Ⅱ Clinical Trial of Safety and Efficacy Evaluation of Long Course Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by TME for LARC.

TypeinterventionalSponsorBeijing Friendship HospitalRan2021 to 2024Enrolled50ConditionsColorectal NeoplasmsArmslong course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 5 syntheses or guidelines pooled it, 19 citations in OpenAlex.

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  17. New Opportunities for Minimizing Toxicity in Rectal Cancer Management.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2023
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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

17 authors at 6 institutions in 1 country.

Jiale GaoDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University & National Clinical Research Center for Digestive Diseases, Beijing, China.
Xiao ZhangDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University & National Clinical Research Center for Digestive Diseases, Beijing, China.
Zhengyang YangDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University & National Clinical Research Center for Digestive Diseases, Beijing, China.
Jie ZhangDepartment of Radiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Zhigang BaiDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University & National Clinical Research Center for Digestive Diseases, Beijing, China.
Wei DengDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University & National Clinical Research Center for Digestive Diseases, Beijing, China.
Guangyong ChenDepartment of Pathology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Rui XuDepartment of Pathology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Qi WeiDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University & National Clinical Research Center for Digestive Diseases, Beijing, China.
Yishan LiuDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University & National Clinical Research Center for Digestive Diseases, Beijing, China.
Jiagang HanDepartment of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
Ang LiDepartment of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China.
Gang LiuDepartment of General Surgery, Tianjin Medical University General Hospital, Tianjin, China.
Yi SunDepartment of Anorectal, Tianjin People's Hospital, Tianjin, China.
Dalu KongDepartment of Colorectal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Hongwei YaoDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University & National Clinical Research Center for Digestive Diseases, Beijing, China.
Zhongtao ZhangDepartment of General Surgery, Beijing Friendship Hospital, Capital Medical University & National Clinical Research Center for Digestive Diseases, Beijing, China.
Capital Medical University · CNBeijing Friendship Hospital · CNNational Clinical Research Center for Digestive Diseases · CNTianjin Medical University Cancer Institute and Hospital · CNTianjin Medical University General Hospital · CNTianjin People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Neoadjuvant chemoradiotherapy is the standard treatment for locally advanced rectal cancer, with modest benefits on tumor regression and survival. Since chemoradiotherapy combined with immune checkpoint inhibitors has been reported to have synergic effects. This study aims to explore the safety and efficacy of long-course chemoradiotherapy combined with concurrent tislelizumab as a neoadjuvant treatment regimen for patients with locally advanced rectal cancer. Methods: This manuscript reported the interim result of a prospective, multicenter, single-arm, phase II trial. Patients with mid-to-low locally advanced rectal cancer with clinical stages of cT3-4a N0M0 or cT1-4a N1-2M0 were included. The patients received long-course radiotherapy (50 Gy/25 f, 2 Gy/f, 5 days/week) and three 21-day cycles of capecitabine (1000 mg/m2, bid, day1-14) plus concurrent three 21-day cycles of tislelizumab (200 mg, day8), followed by a radical surgery 6-8 weeks after radiotherapy. The primary endpoint was the pathological complete response rate. (Clinical trial number: NCT04911517). Results: A total of 26 patients completed the treatment protocol between April 2021 and June 2022. All patients completed chemoradiotherapy, 24 patients received three cycles of tislelizumab, and 2 patients received two cycles. The pathological complete remission (ypT0N0) was achieved in 50% (13/26) of the patients with all proficient mismatch repair tumors. The immune-related adverse event occurred in 19.2% (5/26) of patients. Patients with no CEA elevation or age less than 50 were more likely to benefit from this treatment regimen. Conclusion: Long-course chemoradiotherapy combined with concurrent tislelizumab in patients with locally advanced low rectal cancer had favorable safety and efficacy, and does not increase the complication rate of surgery. Further study is needed to confirm these results.

Indexed as

chemoradiotherapycombination therapyimmune checkpoint inhibitorsneoadjuvant therapyrectal cancer

Identifiers

PMID36816939
PMCPMC9933500
OpenAlexW4318978538

What Socratic holds

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LicenceCC BY
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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 Socratic graph.