Evidence map›Paper›PMID 39313964›Full record

Trial reportIntegrative cancer therapies

Conventional Therapy Combined With Quxie Capsule Modulating Gut Microbiome in Metastatic Colorectal Cancer Patients With the Third or Above Line Setting: Result From an Investigator-Initiated, Open-Label, Single-Arm, Phase II Study.

Zhien Gu, Lei Wang, Jiawei Zhai Ma, Tong Zhang, Yufei Yang

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Integrative cancer therapies. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
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

5 authors.

Zhien GuChina Academy of Chinese Medical Sciences, Beijing, China.ORCID 0009-0006-3849-0764
Lei WangChongqing University Three Gorges Hospital, Chongqing, China.
Jiawei Zhai MaBeijing Chaoyang Integrative Medicinerescue and First Aid Hospital, Beijing, China.
Tong ZhangChina Academy of Chinese Medical Sciences, Beijing, China.
Yufei YangChina Academy of Chinese Medical Sciences, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with metastatic colorectal cancer (mCRC), Quxie Cap-sule (QX)-a combination of conventional therapy (including chemotherapy, targeted therapy or supportive care)-has shown a significant overall survival benefit compared with placebo and might have the property of dual effects of antitumor and immunity enhancement, both mediated by the microbiome. In preclinical models, QX has also shown activity against colorectal cancer. This study aimed to describe how the aforementioned effects of QX look after when focusing on the patients in third or above line setting.

methodsA Simon's Minimax two-stage phase II design was used in this study, which enrolled mCRC patients who progressed after second-line treatment. Patients received conventional therapy plus QX until disease progression or unacceptable toxicity. Before and after 1-month intervention, we collected patients' stool samples for microbiome analysis by 16s rRNA sequencing approaches. And the microbiome analysis before and after 1-month intervention was done through bioinformation analysis platform.

resultsFifteen patients were enrolled and gut microbiome were analyzed from 7 of 10 patients that with PFS over 3.7 months. Microbiome community analysis on genus level showed that the proportion of

conclusionsDecrease of gut bacteria with potential roles in carcinogenesis of colorectal cancer and increase in the abundance of gut anticancer bacteria such as

trial registrationChinese Clinical Trial Registry (ChiCTR2100053874).

Indexed as

Colorectal NeoplasmsGastrointestinal MicrobiomeAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCapsulesDrugs, Chinese HerbalFecesFemaleHumansMaleMiddle AgedNeoplasm MetastasisCapsulesDrugs, Chinese Herbalgut microbiomemetastatic colorectal cancer (mCRC)Quxie capsulethird or above line treatmenttraditional Chinese medicine

Identifiers

PMID39313964
PMCPMC11425756

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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.