Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

NCT06255262 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: DOMESTIC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

A Real-World Study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment.

Conditions

Biliary Tract Cancer

Keywords

Maintenance therapy; Durvalumab; Surufatinib

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival 1 (PFS1)

  PFS1 defined as the time from the initiation of first-line treatment to tumor progression or death.

  2 years

Secondary Outcomes (7)

• Safety(number and degree of adverse events)

  2 years

• Progression-free survival 2 (PFS2)

  2 years

• 1-year survival rate（OS12）

  2 years

• Objective Response Rate(ORR,investigator-assessed RECIST 1.1/mRECIST)

  2 years

• Disease Control Rate(DCR)

  2 years

Study Arms (1)

Durvalumab in combination with surufatinib

EXPERIMENTAL

1. Safety introduction phase (6 cases) 2. Dose expansion phase (24 cases)

Drug: Surufatinib; Drug: Durvalumab

Interventions

Surufatinib DRUG

(1) Safety introduction phase (6 cases): 250mg, oral, QD,after one cycle of combined treatment, the occurrence of DLT was evaluated: 1) If ≤1person occurs, continue the dose expansion study at that dose level. 2)In the event of DLT\> 1, then the dose of surufatinib was adjusted to 200mg，oral，QD,until disease progression or intolerance of toxicity. (2) Dose expansion phase (24 cases): RP2D, oral, QD,until disease progression or intolerance of toxicity.

Also known as: SULANDA, HMPL-012

Durvalumab in combination with surufatinib

Durvalumab DRUG

1500mg, Q4W.iv.every 28 days; until disease progression or intolerance of toxicity.

Also known as: IMFINZI

Durvalumab in combination with surufatinib

Eligibility Criteria

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

You may qualify if:

• Age: ≥18 years
• Expected survival is more than 3 months (12 weeks)
• Patients with unresectable advanced or metastatic BTC confirmed by histopathological and/or cytological examination， including bile duct epithelial cell carcinoma (intrahepatic or extrahepatic), gallbladder
• Patients received durvalumab plus GemCis as first-line therapy for 4-8 cycles（ Cycles of chemotherapy were determined according to the investigator and safety profile. In addition, durvalumab plus GemCis was considered to be first-line therapy if the patient had received only antineoplastic traditional Chinese medicine or immunomodulatory therapy before treatment ）,without disease progression (i.e., according to the evaluation of RECIST v1.1 CR, PR or SD)
• At enrollment, World Health Organization (WHO) /ECOG performance status (PS) was 0-1
• In the first-line treatment at least 1 RECIST 1.1 standard target lesion (TL)
• Organs and bone marrow are sufficiently functional, defined as follows:
• Hemoglobin ≥7g/dL Absolute neutrophil count ≥1.5 × 109/L The platelet count was ≥ 90 × 109/L Serum bilirubin ≤2.0 × upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be 2.5 × ULN or less. For patients with liver metastases, ALT and AST should be ≤5 × ULN Creatinine clearance, calculated by means of the Cockcroft-Gault (based on actual body weight) formula or the 24-hour urinary creatinine clearance assay, should be greater than 50 mL /min
• Weight: \> 30kg
• Female subjects promised to be nonpregnant before enrollment, had to be nonlactating, and agreed to use highly effective contraception for the duration of the study
• Male patients who had sex with a female partner of potential pregnancy had to use an acceptable method of contraception from screening through the duration of the study and the drug washout period to prevent their partner from becoming pregnant
• Patients voluntarily participated in the trial, signed informed consent, and complied with the agreement, including receiving treatment, regular visits and examinations, and follow-up.

You may not qualify if:

• Carcinoma of ampulla
• Any evidence of disease, as judged by the investigator（such as severe or uncontrolled systemic disease, including hypertension that is not controlled by drugs, active bleeding disease, active infection, active ILD/ interstitial lung disease, severe chronic gastrointestinal disease related to diarrhea, mental illness/social conditions）, or a history of allogeneic transplantation that was deemed by the investigator to be inappropriate for study participation or to interfere with adherence to the study protocol
• Active or previously documented autoimmune or inflammatory disease, these include inflammatory bowel diseases \[such as colitis or Crohn's disease\], diverticulitis \[except diverticulosis\], systemic lupus erythematosus, sarcoid syndrome, Wegener syndrome \[granulomatosis with polyangiitis\], Graves disease, rheumatoid arthritis, hypophysitis and uveitis. Exceptions to this criterion are made in the following cases:
• Subjects with vitiligo or alopecia ubjects with hypothyroidism (e.g., after Hashimoto's syndrome) whose condition is stable with hormone-replacement therapy Subjects with any chronic skin disease who did not require systemic treatment Subjects who had not had active disease within the previous 5 years could be enrolled, but only after consultation with a study physician Subjects with celiac disease that could be controlled by diet alone Subjects with ≥ grade 2 lymphopenia will be evaluated on a case-by-case basis after consultation a graduate physician.
• A history of other primary malignancies, except for:Malignancies treated with curative treatment, known no active disease for more than 5 years before the first study intervention, and low potential recurrence；Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has received potentially curative treatment；Or carcinoma in situ that has been adequately treated without evidence of disease
• History of meningeal carcinomatosis
• A history of active primary immunodeficiency
• Active infections, including tuberculosis (clinical assessment, including the clinical history, physical examination and imaging results, and on the basis of the local operation of tuberculosis examination), or human immunodeficiency virus (HIV 1/2 antibody positive)
• Other approved or investigational antiangiogenic tyrosine kinase inhibitors or monoclonal antibodies were received before the initiation of study treatment
• Caused by past anti-tumor treatment for toxic effects (CTCAE\>Grade 2), except for alopecia and vitiligo Subjects with ≥ grade 2 neurological disease will be evaluated on a case-by-case basis after consultation with the study physician Subjects who had an unreasonable expectation of worsening irreversible toxicity from treatment with durvalumab had to consult a study physician before they could be enrolled
• Existing medical conditions or history of brain metastases or spinal cord compression (including asymptomatic and adequately treated disease)
• Known allergies or hypersensitivity reactions to any of the study intervention treatments or any of the study intervention treatment excipients
• Any medical, biologic, or hormonal therapy for cancer that was not permitted in the protocol was used concomitantly. At the same time use hormone therapy of tumor related diseases (such as hormone replacement therapy) is acceptable
• Patients had received live attenuated vaccine within 30 days before the first dose of the study intervention. During the study intervention therapy and the last up to 30 days after the drug into the group of patients are not allowed to accept live vaccine inoculation
• Major surgical procedure (investigator-defined) within 28 days before the first dose

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (4)

Anshan Cancer Hospital

Anshan, Liaoning, 110001, China

Location

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 110001, China

Location

First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shenyang Fifth People's Hospital

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

surufatinib; durvalumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Yunpeng Liu, PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

• Xiujuan Qu, PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunpeng Liu, PhD

CONTACT

86-24-83282312; cmu_trial@163.com

Zan Teng, PhD

CONTACT

+862483282312; tengzan@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Oncology

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: February 15, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

CN (4)