OncoMatch/Clinical Trials/NCT06856837
- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases
Is NCT06856837 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Fruquintinib and Tislelizumab for metastatic colorectal cancer.
Treatment: Fruquintinib · Tislelizumab · Trifluridine/tipiracil · Bevacizumab — This is a prospective, randomized, open-label, multicenter phase II investigating the therapy of Fruquintinib in combination with Tislelizumab in patients with MSS/pMMR metastatic colorectal cancer without liver metastases.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 proficient mismatch repair
microsatellite stable (MSS)/proficient mismatch repair (pMMR)
Required: MSH6 proficient mismatch repair
microsatellite stable (MSS)/proficient mismatch repair (pMMR)
Required: MLH1 proficient mismatch repair
microsatellite stable (MSS)/proficient mismatch repair (pMMR)
Required: PMS2 proficient mismatch repair
microsatellite stable (MSS)/proficient mismatch repair (pMMR)
Allowed: KRAS mutation
Known RAS (KRAS or NRAS) and BRAF V600E mutational status. Note: These mutations are mutually exclusive. Therefore, if one of the factors is mutated, it is not required to determine the mutation status of the others, as they are then assumed to be wildtype.
Allowed: NRAS mutation
Known RAS (KRAS or NRAS) and BRAF V600E mutational status. Note: These mutations are mutually exclusive. Therefore, if one of the factors is mutated, it is not required to determine the mutation status of the others, as they are then assumed to be wildtype.
Allowed: BRAF V600E
Known RAS (KRAS or NRAS) and BRAF V600E mutational status. Note: These mutations are mutually exclusive. Therefore, if one of the factors is mutated, it is not required to determine the mutation status of the others, as they are then assumed to be wildtype.
Disease stage
Required: Stage IV
Metastatic disease required
metastatic adenocarcinoma of the colon or rectum, which is not amenable to potentially curative resection
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine — advanced
Patient received at least one line of previous treatment with a fluoropyrimidine
Must have received: oxaliplatin — advanced
Patient received at least one line of previous treatment with ... oxaliplatin
Must have received: irinotecan — advanced
Patient received at least one line of previous treatment with ... irinotecan
Must have received: VEGF(R) inhibitor — advanced
Patient received at least one line of previous treatment with ... VEGF(R)
Cannot have received: Fruquintinib (Fruquintinib)
Patient received previous treatment with Fruquintinib
Cannot have received: trifluridine/tipiracil (trifluridine/tipiracil)
Patient received previous treatment with ... trifluridine/tipiracil
Cannot have received: regorafenib (regorafenib)
Patient received previous treatment with ... regorafenib
Cannot have received: anti-PD-1 therapy
Patient received previous treatment with ... anti-PD-1/anti-PD-L1 antibodies
Cannot have received: anti-PD-L1 therapy
Patient received previous treatment with ... anti-PD-1/anti-PD-L1 antibodies
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L
Kidney function
Serum creatinine ≤ 1.5 x ULN or creatinine clearance (measured by 24 h urine) ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN (or < 2 x ULN in case of prior liver involvement or Gilbert's disease); AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN, AP ≤ 5 x ULN
Cardiac function
No impaired cardiac function or clinically significant cardiac disease including unstable angina within 6 months, acute myocardial infarction < 6 months, NYHA class II-IV congestive heart failure, uncontrolled hypertension (>160/100 mmHg), uncontrolled cardiac arrhythmias requiring antiarrhythmic therapy other than beta blockers or digoxin, active coronary artery disease or QTc ≥ 470
Patient has adequate hematological, hepatic and renal function. ... Patient has impaired cardiac function or clinically significant cardiac disease including unstable angina within 6 months before the first dose of study treatment, acute myocardial infarction < 6 months prior to the first dose of study treatment, New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension (defined as an average systolic blood pressure > 160 mmHg or diastolic > 100 mmHg despite optimal treatment, uncontrolled cardiac arrhythmias requiring antiarrhythmic therapy other than beta blockers or digoxin, active coronary artery disease or corrected QT interval (QTc) ≥ 470.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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