Sintilimab Combined With Regorafenib and HAIC in Patients With Colorectal Liver Metastasis

NCT05524155 | Unknown Phase 2

• 1 other identifier: SRHCL
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety and efficacy of sintilimab combined with regorafenib and HAIC in patients with colorectal liver metastasis who failed second-line therapy

Conditions

Colorectal Cancer; Liver Metastasis

Keywords

Colorectal Liver Metastasis; Sintilimab; Regorafenib; HAIC

Outcome Measures

Primary Outcomes (2)

• Adverse Events (AEs)

  Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0

  up to 24 months

• Overall response rate ( ORR)

  Defined as proportion of patients who have a best response of CR or PR

  up to 24 months

Secondary Outcomes (4)

• Disease control rate (DCR)

  up to 24 months

• Duration of response (DoR)

  up to 24 months

• Progression free survival (PFS)

  up to 28 months

• Overall survival (OS)

  up to 28 months

Study Arms (1)

Sintilimab Combined With Regorafenib and HAIC

EXPERIMENTAL

Sintilimab Combined With Regorafenib and HAIC

Drug: HAIC; Drug: Sintilimab; Drug: Regorafenib

Interventions

HAIC DRUG

hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment

Also known as: Hepatic Artery Infusion Chemotherapy

Sintilimab Combined With Regorafenib and HAIC

Sintilimab DRUG

200mg IV d1,Q3W

Also known as: IBI308

Sintilimab Combined With Regorafenib and HAIC

Regorafenib DRUG

80mg/day,PO,QD,d1～21,Q4W

Sintilimab Combined With Regorafenib and HAIC

Eligibility Criteria

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

You may qualify if:

• Sign written informed consent before performing any trial related procedures
• ≥ 18 years old
• Histologically or cytologically proven unresectable metastatic colorectal cancer with liver metastases (AJCC 8th IV)
• Intolerance to second-line therapy, or disease progression during or after second-line therapy (RECIST V1.1)
• At least one radiographically measurable lesion, according to the RECIST V1.1 criteria
• Patients with asymptomatic brain metastases or stable symptoms after local treatment were allowed to enroll if they met the following criteria:
• Measurable lesions outside the central nervous system
• No central nervous system symptoms, or symptoms not worsened for at least 2 weeks
• No glucocorticoid therapy was required or glucocorticoid therapy was discontinued within 7 days before the first study drug administration
• Palliative radiation therapy (including craniocerebral radiation for symptomatic brain metastases) was permitted, provided that the radiation had ended at least 1 week before enrollment and that the radiotherapy-related toxicity had recovered to grade 1 or less (CTCAE 5.0, except alopecia).
• ECOG PS scores 0-1
• The expected survival time was \>3 months
• Sufficient organ functions, the subjects need to meet the following laboratory indicators:
• ANC ≥1.5×10\^9/L without the use of granulocyte colony-stimulating factor in the last 14 days
• Platelets ≥90×10\^9/ without blood transfusion in the past 14 days

You may not qualify if:

• Previous treatment with regorafenib
• Previous treatment with anti-PD-L1, anti-PD-L2 drugs, or other drugs that stimulates or synergistically inhibits T-cell receptors (e.g., CTLA-4, OX-40, CD137)
• Symptomatic or high risk of obstruction, bleeding, perforation, pneumonia (including noncommunicable pneumonia with previous hormonal therapy and pneumonia in patients receiving treatment)
• Malignancy other than colorectal cancer diagnosed within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or carcinoma in situ after radical resection)
• currently participating in an interventional clinical study treatment, or has received another study drug or used a study device within 4 weeks prior to the first dose
• Systemic systemic therapy with proprietary Chinese medicine or immunomodulatory agents (including thymosin, interferon, and interleukin, except for local use to control pleural effusion) with anti-tumor indications was received within 2 weeks before the first dose
• Active autoimmune disease requiring systemic therapy occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy
• Receiving systemic glucocorticoid therapy (excluding intranasal, inhaled, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose; Physiological doses of glucocorticoids (≤10 mg/day or equivalent prednisone) are permitted
• Blood transfusion within 7 days before the first dose
• Clinically uncontrollable pleural effusion/abdominal effusion
• Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation
• Known allergy to the active ingredient or excipient of the study drug
• Not fully recovered from toxicity and/or complications caused by any intervention (≤ grade 1 or baseline, excluding fatigue or alopecia) before starting treatment
• HIV 1/2 antibody positive
• Untreated active hepatitis B, subjects who met the following criteria could also be enrolled:

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

sintilimab; regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Tongguo Si

CONTACT

18526812877; 18526812877@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 1, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 1, 2022

Record last verified: 2022-08