Evidence map›Paper›PMID 39179622›Full record

Trial reportNature communications2024

Tislelizumab plus cetuximab and irinotecan in refractory microsatellite stable and RAS wild-type metastatic colorectal cancer: a single-arm phase 2 study.

Xiaojing Xu, Luoyan Ai, Keshu Hu, Li Liang, Minzhi Lv, Yan Wang, Yuehong Cui, Wei Li, Qian Li, Shan Yu and 7 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing 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

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

  1. Pooled it
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  7. EGFR: New Insights on Its Activation and Mutation in Tumor and Tumor Immunotherapy.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
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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.

Xiaojing Xu *Department of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Luoyan Ai *Department of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Keshu Hu *Department of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Li Liang *Department of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.ORCID 0000-0002-1694-380X
Minzhi Lv *Cancer Center, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Yan WangDepartment of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Yuehong CuiDepartment of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Wei LiDepartment of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Qian LiDepartment of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Shan YuDepartment of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Yi FengDepartment of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Qing LiuDepartment of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
Ying YangGenecast Biotechnology Co., Ltd, 214104, Wuxi City, Jiangsu, China.
Jiao ZhangGenecast Biotechnology Co., Ltd, 214104, Wuxi City, Jiangsu, China.
Fei XuGenecast Biotechnology Co., Ltd, 214104, Wuxi City, Jiangsu, China.
Yiyi YuDepartment of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China. yu.yiyi@zs-hospital.sh.cn.
Tianshu LiuDepartment of Oncology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China. liu.tianshu@zs-hospital.sh.cn.ORCID 0000-0002-2318-2869

Funding

National Natural Science Foundation of China (National Science Foundation of China) 82272775National Natural Science Foundation of China (National Science Foundation of China) 82373402
6 · The paper itself

Abstract

Immunotherapy confers little to no benefit in the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC). Mechanistic insights suggested that epidermal growth factor receptor (EGFR) antibody plus irinotecan might augment the tumor immune response in mCRC. Therefore, we conducted a proof-of-concept, single-arm, phase 2 study (ChiCTR identifier: ChiCTR2000035642) of a combination treatment regimen including tislelizumab (anti-PD-1), cetuximab (anti-EGFR) and irinotecan in 33 patients with MSS and RAS wild-type (WT) mCRC who were previously treated with ≥2 lines of therapy. The primary endpoint was met, with a confirmed objective response rate of 33%. As secondary endpoints, the disease control rate was 79%, and the median progression-free survival and overall survival were 7.3 and 17.4 months respectively. Among the 33 patients, 32 (97.0%) had treatment-related adverse events (AEs). Three (9.1%) reported grade ≥ 3 AEs, including rash (n = 1), neutropenia (n = 2). The post-hoc evaluation of dynamic circulating tumor DNA using next generation sequencing and the analysis of peripheral immune proteomics landscape using Olink revealed that lower variant allele frequency (VAF) at baseline, greater reduction in VAF on treatment, and a hot peripheral macroenvironment were associated with the treatment response independently. Our study showed the antitumor activity of tislelizumab, cetuximab, and irinotecan combination with a tolerable safety profile in previously treated MSS and RAS WT mCRC.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabColorectal NeoplasmsIrinotecanAdultAgedErbB ReceptorsFemaleHumansMaleMicrosatellite RepeatsMiddle AgedNeoplasm Metastasisras ProteinsAntibodies, Monoclonal, HumanizedCetuximabErbB ReceptorsIrinotecanras Proteinstislelizumab

Identifiers

PMID39179622
PMCPMC11343749

What OpenQuestion holds

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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.