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Perihilar CholangiocarcinomaPhase 2NCT05430698

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

A Phase 2 study testing PD-1antibody plus GEMOX in people with Perihilar Cholangiocarcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Perihilar Cholangiocarcinoma
What is being tested?
PD-1antibody plus GEMOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
31 Jan 2023to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rui Zhang, PhD contact

020-34078840

zhangr95@mail.sysu.edu.cn

Yanfang Ye contact

020-81336505

yeyfang@mail.sysu.edu.cn

China1 site, 1 recruiting

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

    Guangzhou, Guangdong, 376032

    Rui Zhang, PhD, 020-34078840, zhangr95@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: PD-1 Antibody Plus Gemcitabine and Oxaliplatin (GEMOX) as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma Patients With Positively Metastatic Lymph Nodes : a Single Arm, Phase II Trial

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.

Read the detailed description

For perihilar cholangiocarcinoma, radical surgical treatment, such as major hepatectomy combined with total caudate lobe and extrahepatic bile duct resection, remain the potential modality for cure. However, the lymph node tumor metastasis is an independent risk factor for prognosis after radical resection for this disease without distant metastasis. As reported by Nagoya University, Japan, the patients without lymph node tumor metastasis, the 5-year survival rate could reach as high as 67.1% after R0 resection, but the 5-year survival rate was only 22.1% for the patients with lymph node tumor metastasis after R0 resection. Thus, it is urgent to look for an effective adjuvant therapy treatment for these patients with lymph node tumor metastasis. Fluoropyrimidine-based or gemcitabine-based chemotherapy was recommended for these patients by NCCN guidelines. Studies have shown that Gemox chemotherapy (oxaliplatin + gemcitabine) in patients with resected biliary tract cancer has a good benefit in overall survival. However, for extrahepatic cholangiocarcinoma with lymph nodes metastasis, the benefit was limited. In recent years, immunotherapy, such as PD-1 or PD-L1 monoclonal antibody, combined with chemotherapy have shown better results in the palliative treatment of un-resectable biliary tract tumor. However, there is no report on combined immunotherapy with chemotherapy as adjuvant therapy in perihilar cholangiocarcinoma with lymph node tumor metastasis after R0 resection.

Being tested
PD-1antibody plus GEMOX
Keywords
PD-1, GEMOX, Perihilar Cholangiocarcinoma, Positively Metastatic Lymph Nodes
Medical subject headings
Klatskin Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD-1antibody plus GEMOXDrug

    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.
Study groups in NCT05430698
Study groupRoleWhat they receive
PD-1antibody plus GEMOXExperimentalPD-1 antibody plus GEMOX was given as postoperative adjuvant therapy
Receives: Drug: PD-1antibody plus GEMOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The 12-month relapse-free survival rate

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

    Measured: 12 months

Secondary outcomes (5)

  1. The 12-month overall survival rate

    Overall survival rate in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

    Measured: 12 months

  2. The 60-month overall survival rate

    Overall survival rate in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

    Measured: 60 months

  3. Relapse-free survival

    RFS is defined as the time from resection to relapse or death from any cause, whichever occurred first.

    Measured: 60 months

  4. Overall survival

    OS is defined as the time from resection to death from any cause.

    Measured: 60 months

  5. Percentage of participants with adverse events (AEs)

    Number of participants who experienced an adverse event (AE)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start31 Jan 2023
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05430698
Sponsor's protocol ID
LX-GY-2022010
Status last verified
Jul 2025
First submitted
29 May 2022
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • DeOliveira ML, Cunningham SC, Cameron JL, Kamangar F, Winter JM, Lillemoe KD, Choti MA, Yeo CJ, Schulick RD. Cholangiocarcinoma: thirty-one-year experience with 564 patients at a single institution. Ann Surg. 2007 May;245(5):755-62. doi: 10.1097/01.sla.0000251366.62632.d3.

    PubMed 17457168

  • Kang MJ, Lee JL, Kim TW, Lee SS, Ahn S, Park DH, Lee SS, Seo DW, Lee SK, Kim MH. Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma. Acta Oncol. 2012 Sep;51(7):860-6. doi: 10.3109/0284186X.2012.682628. Epub 2012 May 6.

    PubMed 22559158

  • Groot Koerkamp B, Wiggers JK, Allen PJ, Besselink MG, Blumgart LH, Busch OR, Coelen RJ, D'Angelica MI, DeMatteo RP, Gouma DJ, Kingham TP, Jarnagin WR, van Gulik TM. Recurrence Rate and Pattern of Perihilar Cholangiocarcinoma after Curative Intent Resection. J Am Coll Surg. 2015 Dec;221(6):1041-9. doi: 10.1016/j.jamcollsurg.2015.09.005. Epub 2015 Sep 15.

    PubMed 26454735

  • Abdel-Rahman O, Elsayed Z, Elhalawani H. Gemcitabine-based chemotherapy for advanced biliary tract carcinomas. Cochrane Database Syst Rev. 2018 Apr 6;4(4):CD011746. doi: 10.1002/14651858.CD011746.pub2.

    PubMed 29624208

  • Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. doi: 10.1002/bjs.10776.

    PubMed 29405274

  • Nassour I, Mokdad AA, Porembka MR, Choti MA, Polanco PM, Mansour JC, Minter RM, Wang SC, Yopp AC. Adjuvant Therapy Is Associated With Improved Survival in Resected Perihilar Cholangiocarcinoma: A Propensity Matched Study. Ann Surg Oncol. 2018 May;25(5):1193-1201. doi: 10.1245/s10434-018-6388-7. Epub 2018 Feb 27.

    PubMed 29488187

  • Edeline J, Benabdelghani M, Bertaut A, Watelet J, Hammel P, Joly JP, Boudjema K, Fartoux L, Bouhier-Leporrier K, Jouve JL, Faroux R, Guerin-Meyer V, Kurtz JE, Assenat E, Seitz JF, Baumgaertner I, Tougeron D, de la Fouchardiere C, Lombard-Bohas C, Boucher E, Stanbury T, Louvet C, Malka D, Phelip JM. Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study. J Clin Oncol. 2019 Mar 10;37(8):658-667. doi: 10.1200/JCO.18.00050. Epub 2019 Feb 1.

    PubMed 30707660

  • Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, Anthony A, Corrie P, Falk S, Finch-Jones M, Wasan H, Ross P, Wall L, Wadsley J, Evans JTR, Stocken D, Praseedom R, Ma YT, Davidson B, Neoptolemos JP, Iveson T, Raftery J, Zhu S, Cunningham D, Garden OJ, Stubbs C, Valle JW, Bridgewater J; BILCAP study group. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019 May;20(5):663-673. doi: 10.1016/S1470-2045(18)30915-X. Epub 2019 Mar 25.

    PubMed 30922733

  • Ueno M, Ikeda M, Morizane C, Kobayashi S, Ohno I, Kondo S, Okano N, Kimura K, Asada S, Namba Y, Okusaka T, Furuse J. Nivolumab alone or in combination with cisplatin plus gemcitabine in Japanese patients with unresectable or recurrent biliary tract cancer: a non-randomised, multicentre, open-label, phase 1 study. Lancet Gastroenterol Hepatol. 2019 Aug;4(8):611-621. doi: 10.1016/S2468-1253(19)30086-X. Epub 2019 May 17.

    PubMed 31109808

  • Banales JM, Marin JJG, Lamarca A, Rodrigues PM, Khan SA, Roberts LR, Cardinale V, Carpino G, Andersen JB, Braconi C, Calvisi DF, Perugorria MJ, Fabris L, Boulter L, Macias RIR, Gaudio E, Alvaro D, Gradilone SA, Strazzabosco M, Marzioni M, Coulouarn C, Fouassier L, Raggi C, Invernizzi P, Mertens JC, Moncsek A, Ilyas SI, Heimbach J, Koerkamp BG, Bruix J, Forner A, Bridgewater J, Valle JW, Gores GJ. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020 Sep;17(9):557-588. doi: 10.1038/s41575-020-0310-z. Epub 2020 Jun 30.

    PubMed 32606456

  • Chen X, Wu X, Wu H, Gu Y, Shao Y, Shao Q, Zhu F, Li X, Qian X, Hu J, Zhao F, Mao W, Sun J, Wang J, Han G, Li C, Xia Y, Seesaha PK, Zhu D, Li H, Zhang J, Wang G, Wang X, Li X, Shu Y. Camrelizumab plus gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer: a single-arm, open-label, phase II trial. J Immunother Cancer. 2020 Nov;8(2):e001240. doi: 10.1136/jitc-2020-001240.

    PubMed 33172881

  • Itano O, Takemura Y, Kishida N, Tamagawa E, Shinozaki H, Ikeda K, Urakami H, Ei S, Hayatsu S, Suzuki K, Sakuragawa T, Ishii M, Shito M, Aiura K, Fujisaki H, Takano K, Matsui J, Minagawa T, Shinoda M, Kitago M, Abe Y, Yagi H, Oshima G, Hori S, Kitagawa Y. A prospective feasibility study of one-year administration of adjuvant S-1 therapy for resected biliary tract cancer in a multi-institutional trial (Tokyo Study Group for Biliary Cancer: TOSBIC01). BMC Cancer. 2020 Jul 23;20(1):688. doi: 10.1186/s12885-020-07185-6.

    PubMed 32703191

  • Nakahashi K, Ebata T, Yokoyama Y, Igami T, Mizuno T, Yamaguchi J, Onoe S, Watanabe N, Nagino M. How long should follow-up be continued after R0 resection of perihilar cholangiocarcinoma? Surgery. 2020 Oct;168(4):617-624. doi: 10.1016/j.surg.2020.04.068. Epub 2020 Jul 19.

    PubMed 32665142

  • Gao H, Tian T, Li S, Zhang Y, Fu X, Zheng X, Liu N, Jiang A, Ren M, Zhang X, Liang X, Ruan Z, Geng Z, Yao Y. Efficacy Analysis of Adjuvant Chemotherapy with Gemcitabine Plus Platinum or S-1 in Biliary Tract Carcinoma: A Multi-Center Retrospective Study. Cancer Manag Res. 2021 Jan 29;13:889-898. doi: 10.2147/CMAR.S290083. eCollection 2021.

    PubMed 33542660

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1antibody plus GEMOX in people with Perihilar Cholangiocarcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rui Zhang, PhD (020-34078840, zhangr95@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The 12-month relapse-free survival rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05430698, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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