Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer.

NCT06613113 | Recruiting

• 1 other identifier: KY2024PJ169
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the treatment of second-line and above failure MSS(microsatellite stability) metastatic colorectal cancer. The main question it aims to answer is: The efficacy and safety of Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the third line and beyond treatment of MSS metastatic colorectal cancer. Participants will receive the combination of Fruquintinib and Adebrelimab within 3 weeks after completion of high and low dose radiotherapy on metastases until disease progression or intolerable toxicity occurred.

Conditions

MSS Metastatic Colorectal Cancer

Keywords

MSS Metastatic Colorectal Cancer; Fruquintinib; Adebrelimab; High and Low Dose Radiotherapy

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  1 year

Secondary Outcomes (5)

• PFS

  2 years

• OS

  3 years

• DCR

  3 years

• DoR

  3 years

• AE

  3 years

Study Arms (1)

Fruquintinib Group

EXPERIMENTAL

Participants will receive the combination of Fruquintinib and Adebrelimab within 3 weeks after completion of high and low dose radiotherapy on metastases until disease progression or intolerable toxicity occurred.

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

After receiving high and low dose radiotherapy on metastases, the enrolled patients will receive the combination of Fruquintinib and Adebrelimab. RECIST 1.1 standard was used for clinical tumor imaging evaluation every 6 weeks (±7 days). For complete response (CR) ,partial response (PR), or stable disease (SD), the enrolled patients will continue to receive the combination of Fruquintinib and Adebrelimab. Participants will receive the combination of Fruquintinib and Adebrelimab until disease progression or intolerable toxicity occurred.

Also known as: Adebrelimab, high and low dose radiotherapy

Fruquintinib Group

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 old, gender not limited；
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1；
• Previously identified as MSS type mCRC；
• Metastatic colorectal cancer (mCRC) with disease progression after receiving standard second-line treatment according to Chinese Society of Clinical Oncology ( CSCO) guidelines；
• At least one measurable lesion (RECIST 1.1)；
• Be able to adhere to the protocol during the research period；
• Sign the informed consent form.

You may not qualify if:

• For individuals with a history of uncontrolled epilepsy, central nervous system disorders, or mental disorders, the clinical severity of which may hinder the signing of informed consent forms or affect the patient's adherence to oral medication, as determined by the researcher；
• Accompanied by other malignant tumors that have not been cured；
• The baseline blood routine and biochemical indicators of the subject do not meet the following criteria: hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times the normal upper limit; Alkaline phosphatase (ALP) ≤ 2.5 times the normal upper limit value; Serum total bilirubin\<1.5 times the normal upper limit value; Serum creatinine\<1 times the upper limit of normal; Serum albumin ≥ 30g/L；
• Serious (i.e. active) heart disease in clinical practice, such as symptomatic coronary heart disease, congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction in the past 12 months；
• Irreversible coagulation dysfunction or concurrent active massive bleeding；
• Combination of active infections requiring antibiotic treatment；
• Individuals who are allergic to any research drug ingredients；
• Women with concurrent pregnancy or lactation；
• Organ transplantation requires immunosuppressive therapy and long-term hormone therapy；
• Patients with autoimmune diseases；
• There is a history of drug treatment in previous plans。

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead
• Shanghai Shengdi Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

Kaitai Liu

Ningbo, Zhejiang, 315040, China

RECRUITING

MeSH Terms

Interventions

HMPL-013; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Kaitai Liu, doctor

CONTACT

+8613732112205; liukaitai@nbu.edu.cn

Shuang Ye, master

CONTACT

+8615867883987; yeshuang2713@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: August 7, 2024
• Primary Completion: April 30, 2025
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)