RecruitingPhase 2NCT06148402

Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With Unresectable/Metastatic Colorectal Cancer

Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With Unresectable/Metastatic Colorectal Cancer: a Prospective Phase II Study


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

30 participants

Start Date

Nov 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

FOLFOXIRI-based regimen is more used as a first-line therapeutic approach for patients diagnosed with unresectable or metastatic colorectal cancer for its superior efficacy. However, there are no standard recommendations for second-line therapy after progression on FOLFOXIRI with or without targeted therapy. Here, the investigators conduct this open-label, single arm phase II study to evaluate whether fruquintinib in combination with camrelizumab and capecitabine can be the salvage therapy following FOLFOXIRI based regimen for mCRC. Patients diagnosed with unresectable or metastatic colorectal cancer progression on FOLFOXIRI-based regimen are included;or patients have progression or untolerated toxicity with irinotecan, oxaliplatin and fluorouracil successively within one year; patients with BRAF mutation were allowed to receive BRAF inhibitor therapy with or without MEK inhibitor therapy after FOLFOXIRI-based regimen. Patients participated in this study will receive fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, repeated every three weeks. The primary endpoint is Objective Response Rate(ORR). The investigators estimated that 30 patients were necessary. Secondary endpoints include progression-free survival, overall survival, safety, and exploratory ctDNA for efficacy prediction for unresectable or metastatic colorectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — fruquintinib (an anti-blood vessel growth drug), camrelizumab (an immunotherapy drug), and capecitabine (an oral chemotherapy) — as a second-line treatment for patients with advanced colorectal cancer whose disease progressed on a standard chemotherapy regimen called FOLFOXIRI. **You may be eligible if...** - You have advanced colorectal cancer confirmed by biopsy that cannot be surgically removed - Your cancer progressed on or you could not tolerate a first-line chemotherapy regimen containing irinotecan, oxaliplatin, and fluorouracil (FOLFOXIRI) - You are 18 years or older with reasonable overall health (ECOG score 0–2) - You have at least one measurable tumor on imaging - Your blood counts, liver, and kidney function are adequate - Your estimated life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have had anti-cancer treatment within the last 28 days - You have untreated or symptomatic brain metastases - You have serious heart disease, uncontrolled blood pressure, recent blood clots, or a history of gastrointestinal perforation or major bleeding - You have an autoimmune disease or are on immune-suppressing medications - You have active HIV, hepatitis, or another immune deficiency - You have received a live vaccine in the last 28 days - You are pregnant or breastfeeding - You have previously received fruquintinib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFruquintinib plus camrelizumab and capecitabine

fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, q3w


Locations(1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06148402


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