Using PD-1 antibody and GEMOX for treating perihilar cholangiocarcinoma after surgery

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 study is testing if a combination of a PD-1 antibody and GEMOX chemotherapy can help patients with perihilar cholangiocarcinoma who have had surgery and have cancer in their lymph nodes live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05430698 on ClinicalTrials.gov

What this trial studies

This open-label, single-center, non-randomized, single-arm exploratory study aims to evaluate the efficacy and safety of combining PD-1 antibody with GEMOX chemotherapy as postoperative adjuvant therapy for patients with perihilar cholangiocarcinoma who have positively metastatic lymph nodes. The study addresses the urgent need for effective adjuvant treatments for these patients, as current survival rates are significantly lower for those with lymph node metastasis. Participants will receive the treatment after radical surgical resection, and their outcomes will be monitored to assess the potential benefits of this combined approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with perihilar cholangiocarcinoma and positively metastatic lymph nodes who have undergone radical surgery.

Not a fit: Patients who have received systemic treatment within the last 6 months or have severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with perihilar cholangiocarcinoma and lymph node metastasis.

How similar studies have performed: While studies have shown promise in using immunotherapy combined with chemotherapy for unresectable biliary tract tumors, this specific approach in the adjuvant setting for perihilar cholangiocarcinoma is novel and untested.

Eligibility criteria

Inclusion Criteria:

1. The patient must sign an informed consent form;
2. Age 18-75 years old, both male and female;
3. ECOG performance status score (PS score) 0 or 1 point;
4. Child-Pugh score A period;
5. 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.
6. Have not received any systemic treatment within 6 months;
7. 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);
8. For women who are not breastfeeding or pregnant, use contraception during treatment or 12 months after the end of treatment.

Exclusion Criteria:

1. Unresectable PHC patients or postoperative diagnosis of PHC recurrence and metastasis ;
2. Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma;
3. Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months;
4. Severe cardiopulmonary and renal dysfunction;
5. 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);
6. Abnormal coagulation function (PT\>14s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
7. After antiviral treatment, HBV DNA\>2000 copies/ml, HCV RNA\>1000;
8. A history of esophageal and gastric varices, significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
9. 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;
10. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
11. A history of psychotropic drug abuse, alcohol or drug abuse;
12. Known to have a history of severe allergies to any monoclonal antibodies, platinum drugs, or gemcitabine;
13. 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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Chao Liu, PhD — Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
• Study coordinator: Rui Zhang, PhD

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