Adjuvant PD-1 Antibody in Combination With Capecitabine for Patients With ICC at High-Risk of Postoperative Recurrence

NCT04782804 | Unknown Phase 1

• 1 other identifier: HUASHAN006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to observe the effect of PD-1 Antibody（Tislelizumab） Combined With Capecitabine as Adjuvant Therapy to Prevent the Recurrence in High-risk Patients With Cholangiocarcinoma After Curative Resection.

Conditions

Cholangiocarcinoma, Intrahepatic

Keywords

Cholangiocarcinoma; PD1; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• recurrence free survival (RFS)

  the time from liver resection to tumor recurrence or metastasis

  2 years

Secondary Outcomes (1)

• Overall survival

  5 years

Study Arms (2)

Capecitabine

ACTIVE COMPARATOR

Capecitabine as Adjuvant Therapy Oral capecitabine (1250 mg/m²) was given post operatively twice a day on days 1 to 14 of a 3-weekly cycle for 24 weeks (eight cycles), and observation commenced within 16 weeks of surgery.

Drug: Capecitabine

Capecitabine+PD-1 Antibody（Tislelizumab）

EXPERIMENTAL

Capecitabine+PD-1 Antibody（Tislelizumab）as Adjuvant Therapy Oral capecitabine (1250 mg/m²) was given post operatively twice a day on days 1 to 14 of a 3-weekly cycle for 24 weeks (eight cycles), and observation commenced within 16 weeks of surgery. PD-1 Antibody（Tislelizumab, 200mg） was given q3w iv.

Drug: Capecitabine; Drug: PD-1 Antibody（Tislelizumab）

Interventions

Capecitabine DRUG

Capecitabine+PD-1 Antibody（Tislelizumab）as Adjuvant Therapy Oral capecitabine (1250 mg/m²) was given post operatively twice a day on days 1 to 14 of a 3-weekly cycle for 24 weeks (eight cycles), and observation commenced within 16 weeks of surgery.

Also known as: XELODA

Capecitabine; Capecitabine+PD-1 Antibody（Tislelizumab）

PD-1 Antibody（Tislelizumab） DRUG

PD-1 Antibody（Tislelizumab, 200mg） was given q3w iv.

Also known as: Tislelizumab

Capecitabine+PD-1 Antibody（Tislelizumab）

Eligibility Criteria

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

You may qualify if:

• Post R0 resection, pathologically confirmed intrahepatic cholangiocarcinoma.Patients were also pathologically confirmed to have any of the following high-risk factors (ie, positive resection margins, positive lymph nodes, positive perineural invasion, and intrahepatic cholangiocarcinoma \> 5cm in diameter;
• No history of any chemotherapy, radiotherapy, immunotherapy and interventional treatment prior to surgical resection;
• ECoG score 0-1 points;
• Liver function before medication child a, blood routine: WBC \> 2.5 \* 109 / L, PLT \> 60 \* 109 / L, coagulopathy: Pt prolonged \< 2S, ALT \< 150u / L;
• No heart, lung, or kidney function abnormalities were observed;
• No history of major bleeding disorders of the digestive tract;
• Signed informed consent;

You may not qualify if:

• Pregnant or lactating women.
• Patients with other malignant tumor.
• Patients with mental illness.
• Patients participated in other clinical trials in last three months.
• Residual lesions showed by Postoperative digital subtraction angiography(DSA).
• Postoperative patients treated with other targeted drugs, PD1 antibody and other immunotherapies, FOLFOX systemic chemotherapy, and HuaiErKeLi drug treatment

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Lulu@Huashan.Org.Cn

Shanghai, 20040, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Capecitabine; tislelizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Lu Lu

CONTACT

862152887175; lulu@huashan.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the general surgery department, Huashan hospital

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 4, 2021
• Study Start: January 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: May 1, 2024
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

CN (1)