PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma

NCT05430698 | Recruiting Phase 2 DMC

• 1 other identifier: LX-GY-2022010
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

Conditions

Perihilar Cholangiocarcinoma

Keywords

PD-1; GEMOX; Perihilar Cholangiocarcinoma; Positively Metastatic Lymph Nodes

Outcome Measures

Primary Outcomes (1)

• The 12-month relapse-free survival rate

  Relapse-free survival rate in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

  12 months

Secondary Outcomes (5)

• The 12-month overall survival rate

  12 months

• The 60-month overall survival rate

  60 months

• Relapse-free survival

  60 months

• Overall survival

  60 months

• Percentage of participants with adverse events (AEs)

  12 months

Study Arms (1)

PD-1antibody plus GEMOX

EXPERIMENTAL

PD-1 antibody plus GEMOX was given as postoperative adjuvant therapy

Drug: PD-1antibody plus GEMOX

Interventions

PD-1antibody plus GEMOX DRUG

1. PD-1 antibody，200mg，D1，intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : gemcitabine 1000mg/m2,D1，D8；oxaliplatin 100mg/m2,D1，intravenous infusion. 3. Three weeks is a course of treatment,a total of 6-8 courses.

PD-1antibody plus GEMOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must sign an informed consent form;
• Age 18-75 years old, both male and female;
• ECOG performance status score (PS score) 0 or 1 point;
• Child-Pugh score A period;
• Perihepatic cholangiocarcinoma with negative margins and positively metastatic lymph nodes confirmed by histopathology. Abdominal positively metastatic lymph nodes region is not limited. The 16 groups of microscopically positively metastatic lymph nodes can be included.
• Have not received any systemic treatment within 6 months;
• The functional indicators of important organs meet the following requirements (1)Neutrophils≥1.5\*109/L; platelets≥100\*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; (2)Thyroid-stimulating hormone (TSH) ≤ 2 times the upper limit of normal, and T3 and T4 are in the normal range; (3)Bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 3 times the upper limit of normal; (4)Serum creatinine ≤ 1.5 times the upper limit of normal, and creatinine clearance ≥ 60ml/min (calculated by Cockcroft-Gault formula); 8. The subject has at least 1 measurable lesion (according to RECIST1.1);
• For women who are not breastfeeding or pregnant, use contraception during treatment or 12 months after the end of treatment.

You may not qualify if:

• Unresectable PHC patients or postoperative diagnosis of PHC recurrence and metastasis ;
• Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma;
• Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months;
• Severe cardiopulmonary and renal dysfunction;
• Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements);
• Abnormal coagulation function (PT\>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
• After antiviral treatment, HBV DNA\>2000 copies/ml, HCV RNA\>1000;
• A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
• Active infections requiring systemic treatment; patients with active tuberculosis infection within 1 year before enrollment; a history of active tuberculosis infection more than 1 year before enrollment, and no formal anti-tuberculosis treatment or tuberculosis Still in the active period;
• Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
• A history of psychotropic drug abuse, alcohol or drug abuse;
• Known to have a history of severe allergies to any monoclonal antibodies, platinum drugs, or gemcitabine;
• Other factors judged by the investigator may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 376032, China

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Chao Liu, PhD

  Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Zhang, PhD

CONTACT

020-34078840; zhangr95@mail.sysu.edu.cn

Yanfang Ye

CONTACT

020-81336505; yeyfang@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 24, 2022
• Study Start: January 31, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)