Evidence map›Paper›PMID 38565886›Full record

Trial reportSignal transduction and targeted therapy2024

XELOX (capecitabine plus oxaliplatin) plus bevacizumab (anti-VEGF-A antibody) with or without adoptive cell immunotherapy in the treatment of patients with previously untreated metastatic colorectal cancer: a multicenter, open-label, randomized, controlled, phase 3 trial.

Qiu-Zhong Pan, Jing-Jing Zhao, Liang Liu, Dong-Sheng Zhang, Li-Ping Wang, Wen-Wei Hu, De-Sheng Weng, Xiang Xu, Yi-Zhuo Li, Yan Tang and 20 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Signal transduction and targeted therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03950154 (Phase III Clinical Study of PD-1 Monoclonal Antibody-activated Autologous Peripheral Blood T-lymphocyte), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
8.2field-weighted citation impact, top 2% 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.

NCT03950154 phase3unknown statusnot on this map

Phase III Clinical Study of PD-1 Monoclonal Antibody-activated Autologous Peripheral Blood T-lymphocyte (PD1-T) Combined With XELOX and Bevacizumab in the First-line Treatment of Recurrent and Metastatic Colorectal Cancer

TypeinterventionalSponsorTianjin Medical University Cancer Institute and HospitalRan2019 to 2023Enrolled198ConditionsColorectal CancerArmsBevacizumab Injection [Avastin], Oxaliplatin, Capecitabine, PD1-T cells
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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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

30 authors at 6 institutions in 1 country.

Qiu-Zhong Pan *State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Jing-Jing Zhao *State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Liang Liu *Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, 300060, PR China.
Dong-Sheng Zhang *State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Li-Ping Wang *Department of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, PR China.
Wen-Wei Hu *Department of Tumor Biological Treatment, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, 213003, PR China.
De-Sheng Weng *State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Xiang XuDepartment of Stem Cell & Regenerative Medicine, State Key Laboratory of Trauma, Burn and Combined Injury, Daping Hospital, Army Medical University, Chongqing, 400042, PR China.ORCID 0000-0002-1026-2210
Yi-Zhuo LiImaging Diagnosis and Interventional Center, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Yan TangState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Wei-Hong ZhangTianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, 300060, PR China.
Jie-Yao LiDepartment of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, PR China.
Xiao ZhengDepartment of Tumor Biological Treatment, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, 213003, PR China.ORCID 0000-0002-6163-7414
Qi-Jing WangState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Yong-Qiang LiState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Tong XiangState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Li ZhouTianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, 300060, PR China.
Shuang-Ning YangDepartment of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, PR China.
Chen WuDepartment of Tumor Biological Treatment, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, 213003, PR China.
Rong-Xing HuangState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Jia HeState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Wei-Jiao DuTianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, 300060, PR China.
Lu-Jun ChenDepartment of Tumor Biological Treatment, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, 213003, PR China.
Yue-Na WuState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China.
Bin XuDepartment of Tumor Biological Treatment, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, 213003, PR China.
Qiong ShenDepartment of Tumor Biological Treatment, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, 213003, PR China.
Yi ZhangDepartment of Oncology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, PR China. yizhang@zzu.edu.cn.ORCID 0000-0001-9861-4681
Jing-Ting JiangDepartment of Tumor Biological Treatment, the Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu, 213003, PR China. jiangjingting@suda.edu.cn.
Xiu-Bao RenTianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin, 300060, PR China. renxiubao@tjmuch.com.ORCID 0000-0003-4137-2049
Jian-Chuan XiaState Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, 510060, PR China. xiajch@mail.sysu.edu.cn.ORCID 0000-0002-1268-3967
Sun Yat-sen University · CNSoochow University · CNTianjin Medical University Cancer Institute and Hospital · CNFirst Affiliated Hospital of Zhengzhou University · CNArmy Medical University · CNJiangsu University · CN

Funding

National Natural Science Foundation of China (National Science Foundation of China) 81773110
6 · The paper itself

Abstract

Fluoropyrimidine-based combination chemotherapy plus targeted therapy is the standard initial treatment for unresectable metastatic colorectal cancer (mCRC), but the prognosis remains poor. This phase 3 trial (ClinicalTrials.gov: NCT03950154) assessed the efficacy and adverse events (AEs) of the combination of PD-1 blockade-activated DC-CIK (PD1-T) cells with XELOX plus bevacizumab as a first-line therapy in patients with mCRC. A total of 202 participants were enrolled and randomly assigned in a 1:1 ratio to receive either first-line XELOX plus bevacizumab (the control group, n = 102) or the same regimen plus autologous PD1-T cell immunotherapy (the immunotherapy group, n = 100) every 21 days for up to 6 cycles, followed by maintenance treatment with capecitabine and bevacizumab. The main endpoint of the trial was progression-free survival (PFS). The median follow-up was 19.5 months. Median PFS was 14.8 months (95% CI, 11.6-18.0) for the immunotherapy group compared with 9.9 months (8.0-11.8) for the control group (hazard ratio [HR], 0.60 [95% CI, 0.40-0.88]; p = 0.009). Median overall survival (OS) was not reached for the immunotherapy group and 25.6 months (95% CI, 18.3-32.8) for the control group (HR, 0.57 [95% CI, 0.33-0.98]; p = 0.043). Grade 3 or higher AEs occurred in 20.0% of patients in the immunotherapy group and 23.5% in the control groups, with no toxicity-associated deaths reported. The addition of PD1-T cells to first-line XELOX plus bevacizumab demonstrates significant clinical improvement of PFS and OS with well tolerability in patients with previously untreated mCRC.

Indexed as

Colonic NeoplasmsColorectal NeoplasmsOxaloacetatesAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineFluorouracilHumansImmunotherapyOxaliplatinBevacizumabCapecitabineFluorouracilOxaliplatinOxaloacetates

Identifiers

PMID38565886
PMCPMC10987514
OpenAlexW4393403260

What OpenQuestion holds

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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 OpenQuestion graph.