Trial reportBritish journal of cancer2020
TG01/GM-CSF and adjuvant gemcitabine in patients with resected RAS-mutant adenocarcinoma of the pancreas (CT TG01-01): a single-arm, phase 1/2 trial.
Trial report in British journal of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02261714 (A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients With Resected Adenocarcinoma of the Pancreas), which is not on this map. Cited by 46 papers.
What it found
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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.
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.
A Phase I/II Trial of TG01 and Gemcitabine as Adjuvant Therapy for Treating Patients With Resected Adenocarcinoma of the Pancreas
Who cites it
46 citing papers in PubMed, 65 citations in OpenAlex.
- Lymph node-targeted, mKRAS-specific amphiphile vaccine in pancreatic cancer: the randomized phase 2 AMPLIFY-7P trial.Nature medicine · 2026Article
- Review
- Harnessing Vaccines in the Treatment of Solid Tumors: Advances, Challenges, and Future Directions.Vaccines · 2026Review
- Oncogene Mutations: The Shared Antigen Vaccines That Work?Annual review of medicine · 2026Review
- Immunoinformatic insights for design and clinical prospects of pan-RAS cancer vaccine.Frontiers in medicine · 2026Article
- Key Considerations for TargetingDrug design, development and therapy · 2026Review
- Driving Precision Medicine in Pancreatic Cancer With Molecular Genetics.Seminars in radiation oncology · 2025Review
- KRAS mRNA Spleen-Targeting Lipid Nanoparticles Synergize with Irinotecan Silicasomes to Robustly Augment the Cancer Immunity Cycle in Pancreatic Cancer.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- KRAS: the Achilles' heel of pancreas cancer biology.The Journal of clinical investigation · 2025Review
- Reversing the "cold" tumor microenvironment: the role of neoantigen vaccines in prostate cancer.Journal of translational medicine · 2025Article
- Evolving concepts in adjuvant/neoadjuvant therapy for resectable pancreas cancer.The Journal of clinical investigation · 2025Review
- Review
- Drugging the 'undruggable' KRAS: breakthroughs, challenges, and opportunities in pancreatic cancer.Cancer biology & medicine · 2025Review
- Review
- Article
- Generation of frameshift-mutated TGFβR2-specific T cells in healthy subjects following administration with cancer vaccine candidate FMPV-1/GM-CSF in a phase 1 study.Cancer immunology, immunotherapy : CII · 2025Article
- Article
- A new dawn in cancer immunotherapy: the promise of mutantTranslational gastroenterology and hepatology · 2025Article
- Complementary strategies in pancreatic cancer precision medicine: therapeutic prediction and immune modulation.Frontiers in oncology · 2025Review
- Vaccine therapies for glioma: clinical frontiers and potential breakthrough.Frontiers in oncology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTG01 is the first cancer immunotherapy targeting KRAS oncogenic mutations. This study assessed the safety and efficacy of TG01/GM-CSF in patients with resected pancreatic adenocarcinoma.
methodsPatients with stage I or II pancreatic adenocarcinoma who had undergone surgical resection (R0 or R1) received adjuvant gemcitabine with TG01/GM-CSF using two schedules of vaccination. Immune response was defined as a positive delayed-type hypersensitivity (DTH) response and/or positive T-cell proliferation assay.
resultsThirty-two patients were enrolled between February 2013 and May 2016. Nineteen were treated with the high antigen burden, with four serious adverse reactions considered possibly related to TG01 treatment, including three allergic reactions. On this basis, a further 13 patients received a modified vaccination schedule with reduced antigen burden, with no serious adverse events related to TG01. Ninety-five percent patients in the main cohort and 92% in the modified cohort had a positive immune response. Median overall survival (OS) was 33.1 months, and median disease-free survival (DFS) was 13.9 months for the main cohort. For the modified cohort, the median OS was 34.3 months and median DFS was 19.5 months.
conclusionsTG01/GM-CSF with gemcitabine was well tolerated, with high levels of immune activation. OS and DFS compare favourably with published data for adjuvant gemcitabine. CLINICAL
trial registrationThis clinical trial was registered at ClinicalTrials.gov (NCT02261714).
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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.