## Protocol Section
### Identification Module
**NCT ID:** NCT06430827

**Brief Title:** Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma

**Official Title:** Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma.

#### Organization Study ID Info
**ID:** CSPC-DNY-BTC-02
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** CSPC Ouyi Pharmaceutical Co., Ltd.

#### Lead Sponsor

**Class:** OTHER

**Name:** Ba Yi

#### Responsible Party

**Investigator Affiliation:** Peking Union Medical College Hospital

**Investigator Full Name:** Ba Yi

**Investigator Title:** Director

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.

### Conditions Module

**Conditions:**

- Biliary Tract Carcinoma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine therapy in a 2-week treatment cycle.

**Intervention Names:**

- Drug: irinotecan hydrochloride liposome injection

- Drug: Capecitabine

**Label:** Experimental

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental

**Description:** rinotecan hydrochloride liposome injection (70mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.

**Name:** irinotecan hydrochloride liposome injection

**Other Names:**

- duoenyi

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Experimental

**Description:** Capecitabine (1000 mg/m\^2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle

**Name:** Capecitabine

**Other Names:**

- Kapeitabin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** To evaluate the efficacy of anti-tumor

**Measure:** Progression-free survival (PFS)

**Time Frame:** baseline up to approximately 6 months

#### Secondary Outcomes

**Description:** To evaluate the efficacy of anti-tumor

**Measure:** Objective response rate (ORR)

**Time Frame:** baseline up to approximately 6 months

**Description:** To evaluate the efficacy of anti-tumor

**Measure:** Overall survival (OS)

**Time Frame:** baseline up to approximately 12 months

**Description:** To identify the quality of life by QLQ-C30（V3.0）

**Measure:** Quality of life (QoL)

**Time Frame:** baseline up to approximately 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. The patient had good compliance, could understand the research process of this study, and signed a written informed consent.
2. Age ≥18 years.
3. Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer).
4. Subjects who had received gemcitabine prior first-line therapy and had not received fluorouracil drugs.
5. Subjects who have progressed after receiving previous first-line therapy, relapse within 6 months after the end of (neo) adjuvant therapy is considered as first-line therapy failure.
6. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
8. Has a life expectancy of greater than 3 months.
9. LVEF≥50%.
10. Appropriate organ function is defined as follows: (Hematology and blood biochemistry tests must be completed within 14 days prior to enrollment, and the following criteria are met):

    1. ANC ≥1.5×10\^9/L
    2. Hb≥90g/L
    3. PLT ≥100×10\^9/L
    4. total bilirubin ≤1.5 x ULN
    5. ALT/AST ≤ 2.5 x ULN; When there is liver metastasis, ALT/AST ≤ 5 x ULN
    6. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥50mL/min (according to Cockcroft-Gault fórmula)
    7. Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international standardized ratio (INR) ≤1.5×ULN
11. Patients with biliary obstruction should receive adequate biliary drainage.
12. Adverse reactions caused by previous treatment must be restored to grade 1 or baseline according to CTCAE5.0 (except for toxicity such as alopecias, grade 2 and below peripheral neuropathy, which can be included after the investigator determines that there is no safety risk).
13. non-pregnant or lactating female; Effective contraception should be used by female/Male of childbearing age during the study period and for 6 months after the end of study treatment.
14. There were no contraindications for the use of irinotecan liposomes and capecitabine.

Exclusion Criteria:

1. Patients who have had other malignant tumors within the previous 5 years (except cured carcinoma in situ and skin basal cell carcinoma).
2. Uncontrolled pleural effusion or ascites.
3. Any known brain or meningeal metastases.
4. Subjects were co-administering a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing.
5. Subjects underwent large organ surgery (except needle biopsy, central venous catheterization, port catheterization, stenting for relief of biliary obstruction, percutaneous hepatobiliary drainage, and cholecystostomy) or an elective surgical program within 4 weeks before the first dose of the study drug.
6. Active, uncontrolled bacterial, viral, or fungal infections with systemic treatment, defined as persistent signs/symptoms associated with infection that do not go away despite the use of appropriate antibiotics, antiviral therapy, and/or other treatment, including patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
7. Patients who are known to have dihydropyridine dehydrogenase (low activity) or deficiency.
8. There are serious concomitant diseases: such as uncontrolled diabetes after hypoglycemic drug treatment, uncontrolled hypertension, serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, uncontrolled epilepsy, central nervous system disease or mental disorder history, clear gastrointestinal bleeding tendency, intestinal paralysis, intestinal obstruction, etc.
9. Grade 1 diarrhea with an increase in the number of stools \> 4 times per day compared to baseline; The moderate and severe effluents from stoma increased; Limited activities of daily living with the aid of tools or even self-rational activities of daily living; Life-threatening; Need urgent medical attention.
10. Had participated in other clinical investigators within 4 weeks before enrollment.
11. Unsuitable for participation in the trial by the investigator assessed.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bayipumch@aliyun.com

**Name:** Yi Ba, PHD

**Phone:** +86 010 69158705

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** bayipumch@aliyun.com

- **Name:** Yi Ba, PHD

- **Phone:** +86 010 69158705

- **Role:** CONTACT

**Country:** China

**Facility:** Peking Union Medicalcollege Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** PEKING UNION MEDICALCOLLEGE HOSPITAL

**Name:** Yi Ba

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

### Intervention Browse Module - Ancestors

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000059004

- Term: Topoisomerase I Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1671

- Name: Irinotecan

- Relevance: HIGH

- As Found: International

- ID: M377

- Name: Capecitabine

- Relevance: HIGH

- As Found: Function

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M29349

- Name: Topoisomerase I Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069287

- Term: Capecitabine

- ID: D000077146

- Term: Irinotecan

### Misc Info Module

- Version Holder: 2024-05-31
