Evidence map›Paper›PMID 24297682›Full record

Trial reportCancer chemotherapy and pharmacology2014

First-in-human phase II trial of the botanical formulation PHY906 with capecitabine as second-line therapy in patients with advanced pancreatic cancer.

Muhammad Wasif Saif, Jia Li, Lynne Lamb, Kristin Kaley, Kyle Elligers, Zaoli Jiang, Scott Bussom, Shwu-Huey Liu, Yung-Chi Cheng

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04000737 (A Phase II Randomized Placebo-Controlled Study Investigating The Combination Of YIV-906 And Sorafenib), which is not on this map. Cited by 39 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT04000737 phase2completednot on this mapstarted 2020, after this paper: background citation

A Phase II Randomized Placebo-Controlled Study Investigating The Combination Of YIV-906 And Sorafenib (Nexavar®) In HBV (+) Patients With Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorYiviva Inc.Ran2020 to 2024Enrolled62ConditionsAdvanced Hepatocellular CarcinomaArmsSorafenib+YIV-906, Sorafenib+placebo
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Review
  9. Frontiers in pharmacology · 2024
    Article
  10. Review
  11. Article
  12. Article
  13. Recent Advances inMetabolites · 2022
    Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Frontiers in immunology · 2020
    Article
  19. Article
  20. 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

9 authors at 4 institutions in 1 country.

Muhammad Wasif SaifSection of GI Cancers and Experimental Therapeutics, Tufts University School of Medicine, 800 Washington Street, Boston, MA, 02111, USA, wsaif@tuftsmedicalcenter.org.
Jia Li
Lynne Lamb
Kristin Kaley
Kyle Elligers
Zaoli Jiang
Scott Bussom
Shwu-Huey Liu
Yung-Chi Cheng
Yale University · USPhytoCeutica (United States) · USTufts University · USVA Connecticut Healthcare System · US

Funding

Clinical Study of PHY906, a Novel Chinese Herbal Medicine, as a Modulator of IrinP01CA154295 · NCI · YALE UNIVERSITY · PI CHENG, YUNG-CHI · 2011 to 2016
$6.4M
NCI NIH HHS P01 CA154295NCI NIH HHS P01CA154295
6 · The paper itself

Abstract

backgroundPreclinical studies showed a Chinese botanical formula, PHY906, has synergistic anti-tumor activity with capecitabine. Our phase I study determined maximal tolerated dose of capecitabine 1,500 mg/m(2) BID day 1-7 and PHY906 800 mg BID day 1-4 every 2 weeks. We conducted this phase II study to explore the efficacy of capecitabine and PHY906 in patients with advanced pancreatic cancer who were previously treated with gemcitabine-based regimens.

methodsPatients with pancreatic cancer and an Eastern Cooperative Oncology Group performance status of 0-2 received PHY906 and capecitabine. Toxicity was assessed per NCI-CTCAE v3.0 and response per response evaluation criteria in solid tumors q 6 weeks. Correlative studies of cytokines, chemokines and growth factors were tested using a cytometric bead array. Quality of life was assessed by utilizing Edmonton symptom assessment system. The primary objective was overall survival.

resultsThe study enrolled 25 patients. Median progression-free survival (mPFS) was 10.1 weeks (range 0.4-54.1) and median overall survival (mOS) was 21.6 weeks (range 0.4-84.1). Eighteen patients received at least 2 cycles, and achieved mPFS of 12.3 weeks and mOS of 28 weeks. Six-month survival rate was 44 % (11/25). Unsupervised clustering of patients grouped those with shortened survival together by their cytokine profile showed that only IL-6 had a significant difference (p < .001) between short- and long-term survivors.

conclusionsCapecitabine plus PHY906 provides a safe and feasible salvage therapy after gemcitabine failure for APC. Role of IL-6 in tumor progression and tumor cachexia needs to be investigated with respect to its relation to pathophysiology of pancreatic cancer and development of anti-IL-6 therapeutics.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCapecitabineDeoxycytidineDisease-Free SurvivalDrugs, Chinese HerbalFemaleFluorouracilHumansMaleMiddle AgedPancreatic NeoplasmsSurvival RateTreatment OutcomeCapecitabineDeoxycytidineDrugs, Chinese HerbalFluorouracilPHY 906

Identifiers

PMID24297682
PMCPMC4123311
OpenAlexW1978822224

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.