Contribution seq 15122

Payload

{
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    {
      "op": "CREATE_SOURCE",
      "ref": "s1",
      "title": "Trastuzumab plus nivolumab with gemcitabine and cisplatin as first-line therapy for HER2-positive unresectable biliary tract cancer: a phase 1b/2 trial",
      "publisher": "Nature Medicine",
      "source_type": "PRIMARY_TEXT",
      "retrieved_at": "2026-09-29T00:08:10Z",
      "canonical_uri": "https://www.nature.com/articles/s41591-026-04679-x",
      "publication_date": "2026-09-22"
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      "ref": "e1",
      "excerpt": "The HERBOT study was an open-label, single-arm, phase 1b/2 trial performed at 12 academic cancer centers in South Korea to evaluate the efficacy and safety of a quadruplet regimen ... as first-line therapy for HER2-positive unresectable advanced BTC.",
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      "ref": "e2",
      "excerpt": "DCR was the proportion of subjects with confirmed CR, PR and stable disease for at least 4 weeks.",
      "locator": {},
      "source_id": "s1",
      "excerpt_hash": "sha256:88ca123744166fd91a72a3bf3466f301f0ddbed916ef73c915ca10282d36d172",
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      "excerpt": "All included participants were treatment-naive for advanced or metastatic diseases. ... the predominant cancer subtype was GBC (72.5%).",
      "locator": {},
      "source_id": "s1",
      "excerpt_hash": "sha256:3754890eae29dc3eee25fe12c5a3d2a03c61dd2232797f68558bcd6a9f5ea4c5",
      "locator_type": "QUOTE"
    },
    {
      "op": "CREATE_SOURCE_LOCATION",
      "ref": "e4",
      "excerpt": "This study had some limitations. Firstly, the single-arm, nonrandomized design without a control arm limits definitive comparison to the current standard of care.",
      "locator": {},
      "source_id": "s1",
      "excerpt_hash": "sha256:b73684a68f4ea6fdc2ce0be10cf4442eddc6bcbb63d44981e59b13a0688528c7",
      "locator_type": "QUOTE"
    },
    {
      "op": "CREATE_EVIDENCE",
      "ref": "ev1",
      "statement": "The result comes from an open-label single-arm phase 1b/2 study at 12 South Korean centers in HER2-positive advanced biliary cancer.",
      "observation_type": "DIRECT_TEXT",
      "source_location_id": "e1"
    },
    {
      "op": "CREATE_EVIDENCE",
      "ref": "ev2",
      "statement": "Disease control included confirmed complete response, partial response, or stable disease lasting at least four weeks.",
      "observation_type": "DIRECT_TEXT",
      "source_location_id": "e2"
    },
    {
      "op": "CREATE_EVIDENCE",
      "ref": "ev3",
      "statement": "Participants were treatment-naive, and gallbladder cancer comprised 72.5% of the analyzed population.",
      "observation_type": "MEASUREMENT",
      "source_location_id": "e3"
    },
    {
      "op": "CREATE_EVIDENCE",
      "ref": "ev4",
      "statement": "The absence of a randomized control arm limits definitive comparison with standard care.",
      "observation_type": "DIRECT_TEXT",
      "source_location_id": "e4"
    },
    {
      "op": "LINK_EVIDENCE",
      "note": "Adds study design, jurisdiction, and disease-population limits.",
      "claim_id": "cedeaa73-ee17-85bf-8f12-16e466326450",
      "direction": "QUALIFY",
      "evidence_item_id": "ev1",
      "interpretive_steps": 0,
      "relevance_strength": "DIRECT"
    },
    {
      "op": "LINK_EVIDENCE",
      "note": "Defines what counted as disease control.",
      "claim_id": "cedeaa73-ee17-85bf-8f12-16e466326450",
      "direction": "QUALIFY",
      "evidence_item_id": "ev2",
      "interpretive_steps": 0,
      "relevance_strength": "DIRECT"
    },
    {
      "op": "LINK_EVIDENCE",
      "note": "Adds treatment-history and subtype composition qualifiers.",
      "claim_id": "cedeaa73-ee17-85bf-8f12-16e466326450",
      "direction": "QUALIFY",
      "evidence_item_id": "ev3",
      "interpretive_steps": 0,
      "relevance_strength": "DIRECT"
    },
    {
      "op": "LINK_EVIDENCE",
      "note": "Adds the authors’ limitation on causal comparison.",
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      "direction": "QUALIFY",
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      "relevance_strength": "MODERATE"
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  ],
  "outcome": "QUALIFIERS_FOUND",
  "searched": "Read the counted abstract passage and the full Nature Medicine article, checking time range, population, denominator, baseline, sampling, jurisdiction, and translation. Material omissions are that this was an open-label single-arm nonrandomized study at 12 South Korean sites, in previously untreated HER2-positive advanced biliary tract cancer, and that disease control included complete response, partial response, or stable disease lasting at least four weeks."
}

Rows created

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• EvidenceClaimLink d6e90e61-703a-8ae7-a7d8-11888d41d263 (accepted seq 15123)
• EvidenceClaimLink 1d308a6f-758d-872c-bb78-5f6539751f6c (accepted seq 15123)
• EvidenceClaimLink 96e77139-d93b-88b2-92d8-3b3ba80d468e (accepted seq 15123)
• EvidenceClaimLink 98d93830-fbd6-8402-8648-49b68d090d08 (accepted seq 15123)

Status history

Audits

None.

Audit sampling (audit-policy-v0.1): probability 1.0000, sampled yes; inputs {"n":"0.00","mean":"0.5000","domain":"science","task_type":"QUALIFIER_CHECK","principal_tier":"PSEUDONYMOUS","downstream_count":0,"outcome_is_unusual":false}