Evidence map›Paper›PMID 34725214›Full record

Trial reportJournal for immunotherapy of cancer2021

Phase II, single-arm trial of preoperative short-course radiotherapy followed by chemotherapy and camrelizumab in locally advanced rectal cancer.

Zhenyu Lin, Ming Cai, Peng Zhang, Gang Li, Tao Liu, Xin Li, Kailin Cai, Xiu Nie, Jing Wang, Junli Liu and 14 more

Erratum issued 4 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 101 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 14 pooled it
9.7field-weighted citation impact, top 1% 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.

NCT04231552 phase1 / phase2unknown statusnot on this map

Preoperative Short Course Radiotherapy With Consolidation Chemotherapies and Camrelizumab Followed by Delayed Surgery in Locally Advanced Rectal Cancer

TypeinterventionalSponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRan2019 to 2023Enrolled30ConditionsRectal Cancer, Radiotherapy, ImmunotherapyArmsCamrelizumab
NCT06594692 phase2not yet recruitingnot on this mapstarted 2024, after this paper: background citation

Node-sparing Modified Short-Course Radiation Combined With CAPOX and Sintilimab for MSS Locally Advanced Colon Cancer : A Randomized, Prospective, Multicenter, Open-label Clinical Trial

TypeinterventionalSponsorSir Run Run Shaw HospitalRan2024 to 2026Enrolled140ConditionsMicrosatellite Stable (MSS) Colon Cancer, Locally Advanced Colon CancerArmsNode-Sparing Short-Course Radiotherapy Combined with CAPOX and Sintilimab, CAPOX Chemotherapy
NCT06940388 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer: An Open-label Randomized Controlled Phase II Study (The TOTAL Trial)

TypeinterventionalSponsorbrenner baruchRan2025 to 2030Enrolled134ConditionsLocally Advanced Rectal Cancer (LARC)ArmsTislelizumab, Total neoadjuvant therapy (TNT)
NCT07691632 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Single-Arm, Single-Center, Phase II Exploratory Clinical Study of Serplulimab Combined With Decitabine Plus CAPOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

TypeinterventionalSponsorTianjin Medical University Cancer Institute and HospitalRan2026 to 2027Enrolled35ConditionsLocally Advanced Colorectal Cancer, Colorectal AdenocarcinomaArmsSerplulimab + Decitabine + CAPOX (Oxaliplatin + Capecitabine)
3 · Its place in the literature

Who cites it

101 citing papers in PubMed, 14 syntheses or guidelines pooled it, 162 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

41 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 2 institutions in 1 country.

Zhenyu Lin *Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Ming Cai *Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Peng Zhang *Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Gang LiDepartment of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Tao LiuCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Xin LiDepartment of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Kailin CaiDepartment of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Xiu NieDepartment of Pathology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jing WangCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Junli LiuCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Hongli LiuCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Weikang ZhangDepartment of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jingbo GaoDepartment of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Chuanqing WuDepartment of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Linfang WangDepartment of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Jun FanDepartment of Pathology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Lan ZhangDepartment of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Zheng WangDepartment of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Zhiguo HouDepartment of Medical Affairs, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Chi MaDepartment of Medical Affairs, Jiangsu Hengrui Pharmaceuticals Co., Ltd, Shanghai, China.
Kunyu YangCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Gang WuCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Kaixiong TaoDepartment of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China taozhangxh@hust.edu.cn kaixiongtao@hust.edu.cn.
Tao ZhangCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China taozhangxh@hust.edu.cn kaixiongtao@hust.edu.cn.ORCID 0000-0003-4018-3393
Union Hospital · CNJiangsu Hengrui Medicine (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn locally advanced rectal cancer (LARC), preoperative short-course radiotherapy (SCRT) with delayed surgery has been shown to be as effective as long-course chemoradiotherapy, with only modest benefits. This study aimed to evaluate the efficacy and safety of preoperative SCRT combined with subsequent CAPOX (capecitabine and oxaliplatin) and the anti-PD-1 antibody camrelizumab in patients with LARC.

methodsThis was a prospective, single-arm, phase II trial. Treatment-naïve patients with histologically confirmed T3-4N0M0 or T1-4N+M0 rectal adenocarcinoma received 5×5 Gy SCRT with two subsequent 21-day cycles of CAPOX plus camrelizumab after 1 week, followed by radical surgery after 1 week. The primary endpoint was pathological complete response (pCR) rate. Biomarker analysis was performed to identify a potential predictor of pCR to treatment.

resultsFrom November 7, 2019 to September 14, 2020, 30 patients were enrolled, and 27 patients received at least one dose of CAPOX plus camrelizumab. Surgery was performed in 27 (100%) patients. The pCR (ypT0N0) rate was 48.1% (13/27), including 46.2% (12/26) for proficient mismatch repair (MMR) tumors and 100% (1/1) for deficient MMR tumors. Immune-related adverse events were all grade 1-2, with the most common being reactive cutaneous capillary endothelial proliferation (81.5%). No grade 4/5 adverse events occurred. Biomarker analysis showed patients without FGFR1-3 deletions had a better tendency for pCR.

conclusionsSCRT combined with subsequent CAPOX plus camrelizumab followed by delayed surgery showed a favorable pCR rate with good tolerance in patients with LARC, especially in the proficient MMR setting. A randomized controlled trial is ongoing to confirm these results. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT04231552.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedHumansMiddle AgedPreoperative PeriodProspective StudiesRectal NeoplasmsAntibodies, Monoclonal, Humanizedcamrelizumabclinical trialsgastrointestinal neoplasmsimmunotherapyphase II as topicradiotherapy

Identifiers

PMID34725214
PMCPMC8562535
OpenAlexW3208809668

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.