Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC

NCT06551207 | Recruiting

• 1 other identifier: 2024TJCR020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

An assessment of 6-month progression-free survival in patients with mCRC with third-line and postline metastatic colorectal cancer in combination with cardonilizumab and fuquinitinib and SBRT compared with fuquinitinib monotherapy

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  6-month progression-free survival in patients with third-line and postline metastatic colorectal cancer mCRC with cardonilizumab combined with fuquinitinib and SBRT compared with fuquinitinib monotherapy (6mon-PFS)

  6mon-PFS

Secondary Outcomes (5)

• Obiective response rate (ORR)

  up to 42 months]

• Disease control rate (DCR)

  up to 42 months]

• Overall survival (OS)

  up to 42 months]

• quality of life (QOL)

  up to 42 months]

• AEs

  up to 42 months]

Study Arms (2)

fuquintinib

PLACEBO COMPARATOR

Drug: Fruquintinib

Fuquintinib combined with cardonilizumab and SBRT

EXPERIMENTAL

Drug: Fruquintinib; Drug: Cadonilimab; Radiation: SBRT

Interventions

Fruquintinib DRUG

Fruquintinib:5mg ,qd,po, d1-d14, q3w

Fuquintinib combined with cardonilizumab and SBRT; fuquintinib

Cadonilimab DRUG

Cadonilimab:10mg/kg, ivgtt, d1, q3w

Fuquintinib combined with cardonilizumab and SBRT

SBRT RADIATION

SBRT:8-10Gy×5F, god, in 10 days

Fuquintinib combined with cardonilizumab and SBRT

Eligibility Criteria

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

You may qualify if:

• Age = 18 years, $75 years
• Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer
• MSI status: MSS
• At least two or more standard systemic therapies prior treatment (based on Fu, oxaliplatin, irinotecan, bevacizumab and cetuximab) of cytotoxic chemotherapy, treatment failure or intolerable toxicities
• ECOG 0-1
• Patients must have measurable lesions
• Expected overall survival ≥ 12 weeks
• AST, ALT and alkaline phosphatase s 2.5 times the upper limit of normal (ULN), Serum bilirubin s 1.5 x ULN, creatinine\<ULN
• Prothrombin time (PT), international standard ratio (INR) ≤ 1.5 × ULN
• Patients are allowed to have received radiotherapy, but the time from entering the group must be more than 4 weeks, and the currently selected radiotherapy lesions and evaluable lesions must be lesions that have not received radiotherapy
• Fertile male or female patients voluntarily used an effective contraceptive method during the study period and within 6 months of the last study medication

You may not qualify if:

• Patients have received anti-PD-1 / PD-L1 or anti-CTLA-4 immunotherapy or other immunexperimental drugs
• Patients with severe autoimmune diseases: active inflammatory bowel disease (including Cohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus ervthematosus, autoimmune vasculitis (such as Wegener's granuloma), etc
• Symptomatic interstitial lung disease or active infection/non-infectious pneumonia
• Risk factors of intestinal perforation: active diverticulitis, abdominal abscess, gastrointestinal obstruction, abdominal cancer or other known risk factors of intestinal perforation
• If the patients underwent surgery, they should wait for the wound to heal completely before being considered for enrollment
• History of other malignant tumors ((except for the cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ)
• Patients who are preparinq for or have previously received an organ or allogenic bone marrow transplant
• Moderate or severe ascites with clinical symptoms required therapeutic puncture, drainage or Child-Pugh score \> 2 (except those who only show a small amount of ascites on imaging without clinical symptoms); Uncontrolled or moderate or higher pleural effusion or pericardial effusion
• History of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 6 months before the start of treatment
• Abdominal fistula, gastrointestinal perforation, or abdominal abscess developed within 6 months before the start of study treatment
• Known hereditary or acquired bleeding (e.g. coagulation dysfunction) or thrombotic tendencies, e.g. in hemophiliacs; Currently or recently (within 10 days prior to the start of study therapy) used full dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (allowing prophylactic use of low-dose aspirin, low molecular weight heparin)
• Aspirin (\> 325 mg / day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel (≥ 75 mg) and clostazol are currently used or have been used recently (within 10 days before the start of study treatment)
• Thrombosis or embolism events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction) and pulmonary embolism occurred within 6 months before the start of the study
• Patient with an active infection, heart failure, heart attack, unstable angina pectoris, or unstable arrhythmia within the last 6 months
• Physical examination or clinical trial findings that the investigator believes may interfere with the results or put the patient at increased risk for treatment complications, or other uncontrollable diseases

Sponsors & Collaborators

• Liu Huang: lead

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

HMPL-013

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

Xianglin Yuan, PhD,MD

CONTACT

13667241722; Xlyuan1020@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)