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Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial

Clinical research and mechanism exploration of immunotherapy in colorectal cancer(Tislelizumab With Fruquintinib, Metronidazole, in Mismatch Repair-proficient or Microsatellite Stability, Advanced Colorectal Cancer: a Multicenter, Single Arm, Clinical Trial)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096485
Enrollment
Unknown
Registered
2025-01-24
Start date
2024-04-19
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MSS/ MSI-L colorectal cancer

Interventions

Experimental group:Tislelizumab With Fruquintinib, Metronidazole

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. No gender limit, age >= 18 years old and = 1.5 × 10^9/L, platelet >= 100 × 10^9/L Liver function: ALT and AST = 30g/L Renal function: serum creatinine = 50 mL/min (calculated according to Cockcroft Gault formula). 7. Those who voluntarily participate in the trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Chronic intestinal diseases (such as Crohn's disease, ulcerative colitis, etc.), infectious intestinal diseases during the screening period, and intestinal obstruction during the screening period; 3. Subjects with poor control of hypertension (systolic blood pressure>150 mmHg and/or diastolic blood pressure>100 mmHg) and a history of hypertensive crisis or hypertensive brain disease; 4. Severe liver and kidney function or heart dysfunction; 5. Patients who use antibiotics for more than 5 days within one month prior to immunotherapy; 6. Patients with known brain or meningeal metastases, regardless of whether they have received treatment, are not eligible for inclusion in this trial. 7. Individuals with contraindications to the use of metronidazole medication; 8. Those who are unwilling to participate in the trial or sign informed consent forms; 9. The researchers believe that there are any situations that are not suitable for selection.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Progression-Free-Survival;Overall Survival;Disease Control Rate;Duration of Response;

Countries

China

Contacts

Public ContactFang Jingyuan

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

jingyuanfang@yahoo.com+86 21 58752345

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026