Fruquintinib Plus Camrelizumab and HAIC in the Treatment of Non-MSI-H Advanced Colorectal Cancer

NCT06423937 | Not Yet Recruiting Phase 2

• 1 other identifier: HMPL-013-SH-CRC-106
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Liver metastasis is the main cause of death in patients with colorectal cancer. The treatment of liver metastasis of colorectal cancer is the key to prolong the survival of patients. The purpose of this study was to investigate the efficacy and safety of fruquintinib combined with Camrelizumab and HAIC regimen in the treatment of non-MSI-H advanced colorectal cancer patients with liver metastasis after first-line standard treatment failure. Compared with the current standard second-line treatment plan, it provides new decisions for clinical practice, in order to reduce the adverse reactions of treatment and improve the tolerance and efficacy of patients. To provide more and more optimized medication options for patients with non-MSI-H advanced colorectal cancer complicated with liver metastasis.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

  24 months

Secondary Outcomes (5)

• disease control rate (DCR)

  24 months

• Progression-Free Survival (PFS)

  24 months

• Progression-Free Survival rate at 6 months

  6 months

• overall survival (OS)

  24 months

• Adverse events as assessed by NCI CTCAE v5.0

  24 months

Study Arms (2)

Advanced non-MSI-H left-sided colorectal cancer

EXPERIMENTAL

Advanced non-MSI-H left-sided colorectal cancer with liver metastasis after first-line standard treatment failure

Drug: combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab

Advanced non-MSI-H right-sided colorectal cancer

EXPERIMENTAL

Advanced non-MSI-H right-sided colorectal cancer with liver metastasis after first-line standard treatment failure

Drug: combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab

Interventions

combination therapy Combination: Fruquintinib plus Camrelizumab and HAIC (TOMOX/TOMIRI) Maintenance: Fruquintinib plus Camrelizumab DRUG

Procedure/Surgery: HAIC After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs. TOMOX（Raltitrexed 2 mg/m2, Oxaliplatin 85mg/m2）/ TOMIRI（Raltitrexed 2 mg/m2 ，Irinotecan 120mg/m2） Drug: Fruquintinib 3mg, qd, po, 21 days for a cycle, Suspend medication on the day of HAIC Drug: Camrelizumab 200mg, ivgtt,, 21 days for a cycle

Advanced non-MSI-H left-sided colorectal cancer; Advanced non-MSI-H right-sided colorectal cancer

Eligibility Criteria

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

You may qualify if:

• The subjects volunteered to join the study and signed informed consent, with good compliance and follow-up.
• Patients with histologically or cytologically confirmed non-MSI-H ( according to the detection criteria of the institutional testing center, immunohistochemistry, PCR or NGS detection can be used ) unresectable advanced colorectal cancer with liver metastasis ;
• Age ≥ 18 years, ≤75 years， male or female ;
• ECOG PS 0-1;
• Expected overall survival ≥3 months
• Patients must have at least one measurable liver metastases (RECIST 1.1)
• Patients who had only received one standard first-line systemic treatment and were confirmed to be ineffective, or could not tolerate first-line treatment ;
• Patients must have adequate organ and bone marrow function( No blood components and cell growth factors were used within 14 days before enrollment )
• Male or female patients with fertility voluntarily used effective contraceptive methods, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of treatment in the last study. All female patients will be considered to have fertility, unless the female patient has natural menopause, artificial menopause or sterilization ( such as hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation, etc. ), otherwise the female patient 's serum or urine test showed no pregnancy within 7 days before the study, and must be non-lactating patients.

You may not qualify if:

• Patients who are allergic or suspected to be allergic to the study drug or similar drugs
• Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ);
• Participating in other clinical trials and received at least one treatment within 4 weeks before enrollment
• Patients with autoimmune disease or history of autoimmune disease within 4 weeks before enrollment
• patients currently have central nervous system (CNS) metastasis or previous brain metastasis and the symptom control time is less than 2 months
• Patients cannot take fruquintinib orally
• Patients who have received organ transplantation and bone marrow transplantation in the past
• Have taken other strong inducers or inhibitors of CYP3A4, P-gp substrates and BCRP substrates within 2 weeks before the First medication
• Received any operation (except biopsy) or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment
• Pleural effusion or ascites causing relevant clinical symptoms, including respiratory syndrome (dyspnea≥CTC AE grade 2)
• Clinically significant electrolyte abnormality#
• Systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs
• Proteinuria ≥ 2+ (1.0g/24hr);
• Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI, or other conditions that may cause GI bleeding and perforation as determined by the investigator;
• Have evidence or history of bleeding tendency within 3 months or thromboembolic events within 12 months before enrollment( Hemorrhage \> 30 mL within 3 months, hematemesis, black feces, hematochezia ), hemoptysis ( fresh blood \> 5 mL within 4 weeks ) or thromboembolic events ( including stroke events and / or transient ischemic attack ) within 12 months ;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200062, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

camrelizumab

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

Tan Li

CONTACT

158 0068 0751; 121176421@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver surgery department

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 21, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CN (1)