Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer: a Prospective, Multicenter, Single-arm Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 1.The patients voluntarily participated in the study, signed the informed consent, and had good compliance.

• 2\. Age 18-75 years (including 18 and 75) .

• 3\. Metastatic colorectal cancer confirmed histologically and/or cytologically and initially unresectable.

• 4.MSS or pMMR.

• 5.Patients must have at least one measurable lesion (RECIST 1.1).

• 6.ECOG physical condition 0-1 score.

• 7.Expected survival ≥12 weeks.

• 8.Blood examination (no blood transfusion within 14 days, no correction of granulocyte colony stimulating factor or other hematopoietic stimulating factor within 7 days before laboratory examination).

‣ neutrophil absolute value ≥1.5×109/L, platelets ≥100×109/L, hemoglobin concentration ≥9g/dL)

⁃ Liver function test (bilirubin ≤1.5×ULN; Aspartate aminotransferase and glutamic acid aminotransferase ≤2.5×ULN, AST and ALT≤5×ULN in the case of liver metastasis);

⁃ Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min);

⁃ Coagulation, International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;

⁃ Thyroid function, thyroid stimulating hormone (TSH) ≤ the upper limit of normal (ULN); If there is any abnormality, FT3 and FT4 levels should be examined. If FT3 and FT4 levels are normal, they can be selected.

• 9.Reproductive-age women must have a negative serum pregnancy test within 14 days before treatment and be willing to use a medically acceptable effective contraceptive method (e.g., an intrauterine device, oral contraceptives, or condoms) during the study and for 3 months after the last study dose; for male subjects who are married to a reproductive-age woman, surgical sterilization is required or effective contraception is recommended during the study and for 3 months after the last study dose.

Locations
Other Locations
China
The Fourth Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Jinhua
Contact Information
Primary
Dezhi Li, MD&PhD
mdlidezhi@163.com
15268685138
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 36
Treatments
Experimental: Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab
The enrolled patients with microsatellite stable (MSS) initially unresectable metastatic colorectal cancer will receive a chemotherapy with XELOX and Bevacizumab in combination with Adebrelimab in first-line treatment.~XELOX: Oxaliplatin 130 mg/m2, day 1, q3w; Capecitabine 1000 mg/m2, bid, d1-d14, q3w; Bevacizumab: 7.5mg/kg, intravenous infusion, day 1. q3w. Adebrelimab: intravenously guttae, 1200mg, day 1, q3w. 4 cycles.~Imaging assessment of tumor remission was performed every 8 weeks. Patients who received 4-6 months of treatment and achieved disease control entered the maintenance treatment stage, receiving maintenance treatment:~Bevacizumab: 7.5mg/kg, intravenous infusion, d1, Q3W; Capecitabine: 1250mg/ m2, orally, bid, Q3W; Adebrelimab: 1200mg, intravenous infusion, day 1, Q3W.
Related Therapeutic Areas
Sponsors
Leads: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov

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