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Impact of the number of negative lymph nodes dissected during bile duct tumor surgery on the efficacy of immunotherapy after tumor recurrence

Impact of the number of negative lymph nodes dissected during bile duct tumor surgery on the efficacy of immunotherapy after tumor recurrence

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105094
Enrollment
Unknown
Registered
2025-06-29
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract cancer

Interventions

Pathologically Negative Lymphadenectomy Higher-count Group:None
Pathologically Negative Lymphadenectomy Lower-count Group:None

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Histopathologically confirmed biliary tract malignancy (including intrahepatic cholangiocarcinoma (iCCA), perihilar cholangiocarcinoma (pCCA), distal cholangiocarcinoma (dCCA), and gallbladder carcinoma (GBC)); (2) Underwent resection of the primary tumor with intraoperative lymphadenectomy (removal of at least one lymph node); (3) Postoperative recurrence confirmed by imaging or pathology, followed by ICI therapy.

Exclusion criteria

Exclusion criteria: (1) Presence of distant metastasis or R2 resection (macroscopically positive resection margin), or palliative surgery only; (2) Ampullary carcinoma, neuroendocrine carcinoma, or mixed neuroendocrine-non-neuroendocrine neoplasms; (3) History of concurrent other malignancies (e.g., hepatocellular carcinoma, pancreatic cancer) or autoimmune diseases; (4) Receipt of neoadjuvant chemotherapy, radiotherapy, or immunotherapy prior to surgery; (5) Incomplete clinical data or follow-up information.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Overall survival;Adverse events;Objective response rate;Disease control rate;

Countries

China

Contacts

Public ContactZhang Lei

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

zhangl9@mail.sysu.edu.cn+86 136 0273 0646

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026