{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT07142863","title":"Envafolimab Combined With Neoadjuvant Chemotherapy Treat Stage IIb Resectable Osteosarcoma Patients","sponsor":"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","phases":["PHASE2"],"status":"NOT_YET_RECRUITING","indication":{"slug":"osteosarcoma","name":"Osteosarcoma"},"disease":"osteosarcoma"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"not published","detail":"No target found for the interventions.","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T18:44:44.123Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"not published","detail":"No target found for the interventions.","rule":"Any germline or somatic human genetic evidence for the target in this cancer","source":{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T18:44:44.123Z"},"context":[]},{"id":"pediatric_target","label":"Pediatric target","value":"not published","detail":"No target found for the interventions.","rule":"Target is on FDA's Pediatric Molecular Target List (relevant targets); membership alone neither requires nor waives a study","source":{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"},"context":[]},{"id":"haematologic","label":"Haematologic cancer","value":"no","detail":"Solid tumour","rule":"From the indication, or the registry conditions when no indication matches","source":{"label":"ClinicalTrials.gov NCT07142863","url":"https://clinicaltrials.gov/study/NCT07142863","date":"2026-11-11T18:44:44.123Z"},"context":[{"figure":"Likelihood of approval from phase 1: 7.5% haematologic vs 4.6% solid","dataset":"BIO / Informa / QLS 2021","years":"2011–2020","caveat":"Population-level, not a prediction."}]}],"facts":[{"label":"Targets","text":"Open Targets lists no mechanism-of-action target for Envafolimab and neoadjuvant chemotherapy.","source":{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T18:44:44.123Z"}}],"pending":[{"what":"Normal-tissue expression in vital organs","source":"Human Protein Atlas (ticket 36)"},{"what":"Pan-essential in cell lines","source":"DepMap (ticket 36)"},{"what":"Approved drug on this target","source":"Drugs@FDA (ticket 30)"}]},{"n":2,"question":"Can the result be trusted?","flags":[{"id":"randomised","label":"Randomised","value":"no","detail":"Single group","rule":"Registry allocation field","source":{"label":"ClinicalTrials.gov NCT07142863","url":"https://clinicaltrials.gov/study/NCT07142863","date":"2026-11-11T18:44:44.123Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"yes","detail":"23 planned; each patient moves a rate by 100 ÷ 23 = 4.3 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT07142863","url":"https://clinicaltrials.gov/study/NCT07142863","date":"2026-11-11T18:44:44.123Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"no","detail":"Tumor necrosis rate","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT07142863","url":"https://clinicaltrials.gov/study/NCT07142863","date":"2026-11-11T18:44:44.123Z"},"context":[{"figure":"Non-OS primary endpoint: odds ratio 2.79 for a positive phase 3","dataset":"Otsuka 2021, 400 phase 3 oncology trials","years":"to 2020","caveat":"Shown with the next figure: a surrogate is easier to hit, and often a weak guide to survival."},{"figure":"52% of surrogate-to-OS correlations are low","dataset":"Prasad 2015","years":"published to 2014","caveat":"Shown with the figure above."}]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2026-08-31; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT07142863","url":"https://clinicaltrials.gov/study/NCT07142863","date":"2026-11-11T18:44:44.123Z"},"context":[]}],"facts":[],"pending":[{"what":"Treated and evaluable counts, assessor, confirmed response, follow-up and data cutoff","source":"Readout extraction (ticket 32)"},{"what":"Primary endpoint changed between registry versions","source":"Registry versions in the store (ticket 32)"}]},{"n":3,"question":"What must it beat?","flags":[],"facts":[],"pending":[{"what":"Control-arm result and approved therapies for the same segment, with label links","source":"Drugs@FDA, FDA labels and readouts (tickets 30, 32)"}]},{"n":4,"question":"Too crowded, or too late?","flags":[],"facts":[],"pending":[{"what":"Programs on the target by phase and months behind the leader","source":"Programs and Drugs@FDA (ticket 33)"}]},{"n":5,"question":"Can it be approved, and stay approved?","flags":[{"id":"single_country","label":"Single-country","value":"yes","detail":"The only site is in China","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT07142863","url":"https://clinicaltrials.gov/study/NCT07142863?tab=locations","date":"2026-11-11T18:44:44.123Z"},"context":[]}],"facts":[{"label":"Caveat","text":"Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where the sites are is a fact about the record, not a judgement of its quality."},{"label":"Cited case","text":"In February 2022 FDA asked its Oncologic Drugs Advisory Committee whether sintilimab's application, resting on ORIENT-11, a phase 3 run only in China, needed further trials showing it applies to US patients and US practice. One case, not a rule.","source":{"label":"FDA, ODAC 10 Feb 2022, draft questions","url":"https://www.fda.gov/media/156017/download","date":"2022-02-10"}}],"pending":[{"what":"Precedent approvals for target, modality and endpoint; accelerated-approval status","source":"Drugs@FDA and FDA accelerated-approval tables (ticket 30)"},{"what":"Orphan designation, EU paediatric plan, pediatric incentives","source":"No investigational drug was named, so EMA and FDA records were not looked up"}]},{"n":6,"question":"Can the sponsor finish?","flags":[],"facts":[{"label":"Sponsor","text":"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (academic or other)","source":{"label":"ClinicalTrials.gov NCT07142863","url":"https://clinicaltrials.gov/study/NCT07142863","date":"2026-11-11T18:44:44.123Z"}}],"pending":[{"what":"Filed cash, quarterly spend and the runway arithmetic","source":"SEC XBRL company facts (ticket 37)"},{"what":"Sponsor's completed vs stopped oncology trials and results-reporting record","source":"Registry, by company (ticket 37)"}]}],"limits":"Public records cannot show: sales forecasts; a probability of success for this asset; full deal terms and net prices; FDA designations and action dates before approval (shown only as company-reported); clinical holds unless the company disclosed them; manufacturing; patents on unapproved drugs; whether preclinical findings have been replicated.","sources":[{"label":"ClinicalTrials.gov NCT07142863","url":"https://clinicaltrials.gov/study/NCT07142863","date":"2026-11-11T18:44:44.123Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T18:44:44.123Z"},{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"}]},"source":"ClinicalTrials.gov + Open Targets","fetchedAt":"2026-11-11T18:44:44.120Z"}