Evidence map›Paper›PMID 39764608›Full record

Trial reportInternational journal of surgery (London, England)2025

Safety and clinical efficacy of neoadjuvant chemoradiation therapy with immunotherapy for organ preservation in ultra-low rectal cancer: preliminary results of the CHOICE-I trial: a prospective cohort study.

Leqi Zhou, Guanyu Yu, Yuxin Shen, Rongbo Wen, Haibo Ding, Jidian Zhou, Xiaoming Zhu, Yonggang Hong, Haifeng Gong, Lianjie Liu and 5 more

Abstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of surgery (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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.

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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
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

15 authors.

Leqi ZhouDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Guanyu YuDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Yuxin ShenDepartment of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Rongbo WenDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Haibo DingDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Jidian ZhouDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Xiaoming ZhuDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Yonggang HongDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Haifeng GongDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Lianjie LiuDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Hao WangDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Huojun ZhangDepartment of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Chenguang BaiDepartment of Pathology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Liqiang HaoDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Wei ZhangDepartment of Colorectal Surgery, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo explore the safety and efficacy of neoadjuvant chemoradiotherapy (nCRT) combined with a PD-1 antibody in improving complete clinical response (cCR) and organ preservation in patients with ultra-low rectal cancer.

methodsThis was a prospective phase II, single-arm, open-label trial. Patients with confirmed pMMR status T 1-3a N 0-1 M 0 retcal adenocarcinoma were included. Long-course chemoradiotherapy was delivered to a dose of 50 Gy. A PD-1 antibody was added 2 weeks after the first radiotherapy session, and two courses were administered. After chemoradiotherapy, CapeOX plus PD-1 antibody was administered to patients for two cycles. After evaluation, patients with cCR were managed with a watch-and-wait (W&W) approach. Local excision or a W&W approach was performed for patients with near complete clinical response (ncCR) as per multidisciplinary team decision. Radical surgery was recommended for poorly regressed or progressed tumors.

resultsTwenty-five patients were enrolled, but two patients withdrew from the study. A total of 23 patients completed the entire neoadjuvant therapy. Ten and five patients achieved cCR and ncCR, respectively, and the rest had a partial clinical response. Patients with cCR were managed with W&W. Four patients with ncCR underwent local excision and were managed using W&W. Eight patients with partial clinical response underwent anus-preserving surgery. At the last follow-up, the rectum and anus preservation rates were 63.4% (14/22) and 95.5% (21/22), respectively.

conclusionnCRT combined with immunotherapy tended to achieve better cCR and rectum preservation rates with good tolerance in patients.

Indexed as

AdenocarcinomaChemoradiotherapyChemoradiotherapy, AdjuvantImmunotherapyNeoadjuvant TherapyOrgan Sparing TreatmentsRectal NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedProspective StudiesTreatment Outcome

Identifiers

PMID39764608
PMCPMC12372751

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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.