ReviewThe Lancet. Oncology2017
iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.
Erratum issued 23 registry-linked trialsAbstract readReview
In one paragraph
Review in The Lancet. Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 23 registered trials, which are not on this map. Cited by 1,429 papers, 7 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
1,429citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.
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.
Phase 1b/Study of VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung Cancer
NCT03515798 phase2active not recruitingnot on this mapstarted 2018, after this paper: background citation
A Prospective Multicenter Open-label, Randomized Phase II Study of Pembrolizumab in Combination With Neoadjuvant EC-Paclitaxel Regimen in HER2-negative Inflammatory Breast Cancer.
Cabozantinib Plus Durvalumab in Patients With Advanced and Chemotherapy-treated Bladder Carcinoma, of Urothelial and Non-urothelial Histology: an Open-label, Single-centre, Phase 2, Single-arm Proof-of-concept Trial: ARCADIA Study
PECULIAR: An Open Label, Monocenter, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab and Epacadostat, Preceding Radical Cystectomy, for Patients With Muscle-invasive Bladder Cancer.
Phase II Study of Toripalimab (JS001) Plus Stereotactic Body Radiotherapy in Colorectal Cancer Patients With Oligometastasis
NCT04153734 phase2not yet recruitingnot on this mapstarted 2019, after this paper: background citation
Pembrolizumab + Platinum Doublets Without Radiation for Patients With PD-L1 ≥50% Locally Advanced Non-small Cell Lung Cancer: a Multicenter Prospective Single Arm Phase II Study
A Phase 1, Open-label, Multicenter Study of SYNB1891 Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors and Lymphoma Alone and in Combination With Atezolizumab
NCT04260529 phase1 / phase2completednot on this mapstarted 2020, after this paper: background citation
A First-in-human, Open-label Dose Escalation Followed by Dose Expansion Phase I/IIa Trial to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of Intratumoral CyPep-1 Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Cancers.
Canadian Atezolizumab Precision Targeting for Immunotherapy Intervention
NCT04815720 phase1 / phase2completednot on this mapstarted 2021, after this paper: background citation
A Phase 1b/2 Study of the Combination of Pepinemab and Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
EF-36/Keynote B36: A Pilot, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer
NCT04969315 phase1 / phase2recruitingnot on this mapstarted 2023, after this paper: background citation
Phase I/II First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors
NCT04976660 phase1 / phase2withdrawnnot on this mapstarted 2022, after this paper: background citation
Phase I/II First-in-Human Study of TT-4 As a Single Agent in Participants with Advanced Selected Solid Tumors
StrataPATH™ (Precision Indications for Approved Therapies): A Study Evaluating the Clinical Activity and Safety of Approved Drugs Within Biomarker-Guided Patients With Solid Tumors
Artificial Intelligence to Help Non-Small Cell Lung Cancer Patients: Measure Lung Cancer Biology and Treatment Response Via Imaging
NCT05383170 phase1 / phase2completednot on this mapstarted 2023, after this paper: background citation
A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST)
Observational Lung Trial to Collect Tissue to Train and Validate a Live Tumor Diagnostic Platform (CYBRID-01)
Liver Cancer and Immunotherapy : Clinical Relevance of LIquid BioPSY
A Single Arm, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of B4T2-001 CAR-T in Patients With Advanced Solid Tumors
Pilot, Exploratory, Prospective Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Anti-PD1 Immunotherapy in Initially Long-responder Patients With Metastatic Progression.
NCT06471673 phase1 / phase2recruitingnot on this mapstarted 2024, after this paper: background citation
A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
NCT06579196 phase1 / phase2recruitingnot on this mapstarted 2025, after this paper: background citation
Evaluation of Trabedersen (OT-101) With Pembrolizumab in Patients With Newly Diagnosed Advanced Non-Small Cell Lung Cancer and Positive PD-L1
A Late Phase Randomized Open-Label Multi Cohort Trial to Evaluate irAEs With Different Standard of Care Dosing Strategies of Standard of Care Immunotherapies
Who cites it
1,429 citing papers in PubMed, 7 syntheses or guidelines pooled it.
- Hyperprogressive disease in carcinoma induced by immune checkpoint inhibitor therapy: a systematic review.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Pooled it
- ESR Essentials: imaging of melanoma-practice recommendations by the European Society of Oncologic Imaging.European radiology · 2026Guideline
- Comprehensive Computed Tomography Evaluation of Gastric Cancer: 2026 Consensus Recommendation From the Korean Society of Abdominal Radiology.Korean journal of radiology · 2026Guideline
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of renal cell carcinoma, version 3.0.Journal for immunotherapy of cancer · 2026Guideline
- Diagnostic performance of 18F-FDG PET/CT metabolic parameters for early prediction of pathological response in NSCLC treated with neoadjuvant immuno(chemo)therapy: A systematic review and meta-analysis.European journal of nuclear medicine and molecular imaging · 2026Pooled it
- The mechanism of breast cancer stem cells and tumor microenvironment promoting radioresistance in breast cancer and its intervention strategies.Frontiers in immunology · 2026Pooled it
- CT-based radiomics in predicting the efficacy of preoperative neoadjuvant chemoimmunotherapy for non-small cell lung cancer: a systematic review and meta-analysis.Frontiers in immunology · 2026Pooled it
- Neoadjuvant Atezolizumab and Chemotherapy for Non-Squamous Non-Small Cell Lung Cancer: Efficacy and Safety Results of an Open-Label, Single-Arm, Phase II Trial.International journal of cancer · 2026Trial
- Reprogramming engineered autologous T cells to overcome resistance in patients with Merkel cell carcinoma.Science translational medicine · 2026Trial
- Safety and efficacy of fecal microbiota transplantation in solid cancers resistant to immune checkpoint inhibitors: results of the MITRIC trial.Journal for immunotherapy of cancer · 2026Trial
- Neoadjuvant camrelizumab plus chemotherapy in resectable stage IIIA-IIIB non-small cell lung cancer: integrated multidimensional biomarker analysis from a phase II study.Journal for immunotherapy of cancer · 2026Trial
- Fecal microbiota transplantation plus immunotherapy in non-small cell lung cancer and melanoma: the phase 2 FMT-LUMINate trial.Nature medicine · 2026Trial
- Time-of-day immunochemotherapy in non-small cell lung cancer: a randomized phase 3 trial.Nature medicine · 2026Trial
- [European journal of nuclear medicine and molecular imaging · 2026Trial
- Temporal and spatial composition of the tumor microenvironment predicts response to immune checkpoint inhibition in metastatic TNBC.Nature cancer · 2026Trial
- Evaluation of serum tumor markers in assessing the efficacy of TP (Paclitaxel plus Carboplatin) chemotherapy combined with trastuzumab and pertuzumab dual target therapy in HER2-positive breast cancer.Naunyn-Schmiedeberg's archives of pharmacology · 2026Trial
- Trial
- Carcinoembryonic Antigen Flare Under Oxaliplatin-Based Chemotherapy Predicts Benefit from Nivolumab in Metastatic Microsatellite-Stable Colorectal Cancer - A Post Hoc Analysis of METIMMOX Trial Data.ImmunoTargets and therapy · 2026Trial
- CfDNA-based copy-number dynamics during anti-PD1 treatment in metastatic triple negative breast cancer.Cell reports. Medicine · 2025Trial
- Clinical outcomes and blood-based biomarkers across two SABR-treated metastatic settings: oligoprogression under immune checkpoint inhibition and oligometastatic disease.Oncoimmunology · 2026Observational
1,369 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
19 authors.
Lesley SeymourCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada. Electronic address: lseymour@ctg.queensu.ca.
Jan BogaertsEORTC Headquarters, Brussels, Belgium.
Andrea PerroneTranslational Medicine, Merck & Co, Kenilworth, NJ, USA.
Robert FordClinical Trials Imaging Consulting, LLC, Belle Mead, NJ, USA.
Lawrence H SchwartzDepartment of Radiology, Columbia University Medical Center, New York, NY, USA; New York Presbyterian Hospital, New York, NY, USA.
Sumithra MandrekarDivision of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.
Nancy U LinDepartment of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Saskia LitièreEORTC Headquarters, Brussels, Belgium.
Janet DanceyCanadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Alice ChenEarly Clinical Trials Development Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.
F Stephen HodiDepartment of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Patrick TherasseInstitut de Recherche International Servier, Paris, France.
Otto S HoekstraDepartment of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, Netherlands.
Lalitha K ShankarDiagnostic Imaging Branch, National Cancer Institute, Bethesda, MD, USA.
Jedd D WolchokDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Marcus BallingerWeill Cornell Medical and Graduate Colleges, New York, NY, USA; Ludwig Institute for Cancer Research, New York, NY, USA; Genentech Inc, San Francisco, CA, USA.
Caroline CaramellaDepartment of Radiology, Gustav Roussy Cancer Campus, Villejuif, France.
Elisabeth G E de VriesDepartment of Medical Oncology, University Medical Center Groningen, Groningen, Netherlands.
RECIST working group
Funding
X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4MEORTC HEADQUARTERSU10CA011488 · NCI · EUROPEAN ORG/RES/TREATMENT/CANCER · PI LACOMBE, DENIS · 1985 to 2015
$6.6MNCI NIH HHS P30 CA008748NCI NIH HHS U10 CA011488
Abstract
Tumours respond differently to immunotherapies compared with chemotherapeutic drugs, raising questions about the assessment of changes in tumour burden-a mainstay of evaluation of cancer therapeutics that provides key information about objective response and disease progression. A consensus guideline-iRECIST-was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent design and data collection, facilitate the ongoing collection of trial data, and ultimate validation of the guideline. This guideline describes a standard approach to solid tumour measurements and definitions for objective change in tumour size for use in trials in which an immunotherapy is used. Additionally, it defines the minimum datapoints required from future trials and those currently in development to facilitate the compilation of a data warehouse to use to later validate iRECIST. An unprecedented number of trials have been done, initiated, or are planned to test new immune modulators for cancer therapy using a variety of modified response criteria. This guideline will allow consistent conduct, interpretation, and analysis of trials of immunotherapies.
Indexed as
Response Evaluation Criteria in Solid TumorsDisease ProgressionHumansImmunotherapyNeoplasmsPractice Guidelines as TopicTumor Burden
Identifiers
What OpenQuestion holds
Textmetadata
LicenceTDM
Read underepoch 390
Registered trials
NCT03268057ClinicalTrials.gov
NCT03515798ClinicalTrials.gov
NCT03824691ClinicalTrials.gov
NCT03832673ClinicalTrials.gov
NCT03927898ClinicalTrials.gov
NCT04153734ClinicalTrials.gov
and 17 more above
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.