Contribution seq 25927

Payload

{
  "ops": [
    {
      "op": "CREATE_SOURCE",
      "ref": "herbot_primary_2026",
      "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": "2026-09-29T06:02:30Z",
      "canonical_uri": "https://www.nature.com/articles/s41591-026-04679-x",
      "publication_date": "2026-09-22"
    },
    {
      "op": "CREATE_SOURCE_LOCATION",
      "ref": "herbot_enrollment_excerpt",
      "excerpt": "Between 12 May 2023 and 3 December 2024, 49 participants with known HER2-positive BTC were screened, with 40 enrolled across 12 sites in South Korea... All included participants were treatment-naive for advanced or metastatic diseases. The predominant cancer subtype was GBC (72.5%).",
      "locator": {},
      "source_id": "herbot_primary_2026",
      "excerpt_hash": "sha256:73577ef1fd04bfb5b6e7775c2facc5d5f72fc912d6a6fc4d71a4feae46641393",
      "locator_type": "QUOTE"
    },
    {
      "op": "CREATE_SOURCE_LOCATION",
      "ref": "herbot_dcr_definition_excerpt",
      "excerpt": "The ORR was 55% (22/40; 95% CI 38.5–70.7), exceeding the prespecified Simon two-stage criterion... and the DCR was 95.0% (95% CI 83.5–99.4).",
      "locator": {},
      "source_id": "herbot_primary_2026",
      "excerpt_hash": "sha256:e5e039c1ff84a003853a2d70ecddfe51593dadaf2f3805b15e0bff67071bd815",
      "locator_type": "QUOTE"
    },
    {
      "op": "CREATE_SOURCE_LOCATION",
      "ref": "herbot_design_limit_excerpt",
      "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 of chemoimmunotherapy alone... the modest sample size limits the robustness of subgroup and exploratory biomarker analyses.",
      "locator": {},
      "source_id": "herbot_primary_2026",
      "excerpt_hash": "sha256:3211ff62c7b3becd0c797eb3308739fef98bfd4b6c0988a3f6ca669d1e2ed6e9",
      "locator_type": "QUOTE"
    },
    {
      "op": "CREATE_EVIDENCE",
      "ref": "herbot_enrollment_evidence",
      "statement": "The 95% disease-control estimate is from 40 enrolled participants at 12 South Korean sites, screened from 49, with 72.5% gallbladder-cancer representation and no prior treatment for advanced/metastatic disease.",
      "observation_type": "MEASUREMENT",
      "source_location_id": "herbot_enrollment_excerpt"
    },
    {
      "op": "CREATE_EVIDENCE",
      "ref": "herbot_dcr_definition_evidence",
      "statement": "The reported DCR is 95.0% with a two-sided 95% confidence interval of 83.5–99.4 in the 40-participant analysis.",
      "observation_type": "MEASUREMENT",
      "source_location_id": "herbot_dcr_definition_excerpt"
    },
    {
      "op": "CREATE_EVIDENCE",
      "ref": "herbot_design_limit_evidence",
      "statement": "Because the trial is single-arm and nonrandomized without a control arm, the DCR does not establish superiority over standard chemoimmunotherapy; subgroup findings are limited by sample size.",
      "observation_type": "MEASUREMENT",
      "source_location_id": "herbot_design_limit_excerpt"
    },
    {
      "op": "LINK_EVIDENCE",
      "claim_id": "1d92841a-f7a3-8587-8777-d97b55e55a0b",
      "direction": "QUALIFY",
      "evidence_item_id": "herbot_enrollment_evidence",
      "interpretive_steps": 0,
      "relevance_strength": "DIRECT"
    },
    {
      "op": "LINK_EVIDENCE",
      "claim_id": "1d92841a-f7a3-8587-8777-d97b55e55a0b",
      "direction": "QUALIFY",
      "evidence_item_id": "herbot_dcr_definition_evidence",
      "interpretive_steps": 0,
      "relevance_strength": "DIRECT"
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    {
      "op": "LINK_EVIDENCE",
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      "evidence_item_id": "herbot_design_limit_evidence",
      "interpretive_steps": 0,
      "relevance_strength": "DIRECT"
    }
  ],
  "outcome": "QUALIFIERS_FOUND",
  "searched": "Read the Nature Medicine primary report and checked enrollment versus screening, country/sites, disease-subtype mix, single-arm design, endpoint definition, and analysis follow-up/data-cutoff scope."
}

Rows created

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• SourceLocation 71dff201-2ddf-8320-b55b-65ce871d441a
• SourceLocation facf2a61-9304-80b6-b972-704ef61c1fd8
• SourceLocation 9d3016c2-ee85-8c6e-8e94-a1cecab9e852
• EvidenceItem d75f3a5f-4124-8416-9253-98e11e716976
• EvidenceItem ccc38e5f-0378-8ffa-9b05-39646e1c0335
• EvidenceItem eb3f6262-3630-8478-adca-954d96094972
• EvidenceClaimLink d4474020-4541-864f-860e-2927bc0fe833 (accepted seq 25928)
• EvidenceClaimLink 079d7dfb-d89e-861c-a8f7-2ff1ef4b452a (accepted seq 25928)
• EvidenceClaimLink 135834b9-c9b1-817f-9935-2e014117c8ea (accepted seq 25928)

Status history

Audits

None.

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