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

NCT06168786 | Recruiting Phase 2

• 1 other identifier: CRC-II-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II Study to Assess the Efficacy and Safety of Cadonilimab Combined With Fruquintinib and SBRT as A third-line and Posterior Line Treatment in Patients With MSS Colorectal Cancer

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  To assess the efficacy of Cadonilimab Combined With Fruquintinib and SBRT for patients with advanced colorectal cancer by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

  up to 42 months

Secondary Outcomes (5)

• Objective response rate (ORR)

  up to 42 months

• Disease control rate (DCR)

  up to 42 months

• Overall survival (OS)

  until death

• quality of life (QOL)

  up to 42 months

• AEs

  up to 42 months

Study Arms (1)

Cadonilimab plus Fruquintinib and SBRT

EXPERIMENTAL

Drug: Fruquintinib; Drug: Cadonilimab; Radiation: SBRT

Interventions

Fruquintinib DRUG

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

Cadonilimab plus Fruquintinib and SBRT

Cadonilimab DRUG

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

Cadonilimab plus Fruquintinib and SBRT

SBRT RADIATION

SBRT:8-10Gy×5F，qod， in 10 days

Cadonilimab plus Fruquintinib 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:

• Provision of written Informed Consent Form (ICF) prior to any study specific procedures
• 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 ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 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 immunoexperimental drugs
• Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, 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 preparing for or have previously received an organ or allogeneic 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 cilostazol 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

• Huazhong University of Science and Technology: 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

CONTACT

13667241722; xlyuan1020@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: Huazhong University of Science and Technology

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: June 20, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)