Health Trials

About this trial

A randomized, controlled, multicenter clinical study of SHR-A1811 combined with bevacizumab for the second-line treatment of metastatic colorectal cancer

Eligibility criteria

Qualifiers

Patients with histologically or cytologically confirmed recurrent or metastatic colorectal adenocarcinoma that is not amenable to curative resection.

Patients who have experienced disease progression following first-line standard therapy with oxaliplatin combined with fluoropyrimidine-based drugs.

Patients with disease progression within 12 months after completion of neoadjuvant or adjuvant therapy are eligible for inclusion.

Patients who have previously received irinotecan as part of first-line therapy may be included if investigators from the leading center determine through discussion that the patient is likely to benefit from treatment in the control group.

Disqualifiers

Toxicities from prior anti-tumor therapies have not resolved to ≤ Grade 1 per the CTCAE v5.0 criteria (except for toxicities deemed to pose no safety risk by the investigator, e.g., alopecia) or to the levels specified in the inclusion/exclusion criteria.

Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with a history of treated brain metastases may be enrolled provided that their brain metastases are stable, and they have not received steroid therapy for brain metastases for at least 28 days prior to study initiation. This exception does not apply to carcinomatous meningitis, as patients with carcinomatous meningitis are excluded regardless of clinical stability.

Known microsatellite instability-high (MSI-H) status confirmed by genetic testing or deficient mismatch repair (dMMR) status confirmed by immunohistochemistry.

A history of hypersensitivity to monoclonal antibodies, the formulation components of SHR-A1811, or anti-angiogenic agents.

Trial design

Treatments tested in this trial

  • SHR-A1811 & Bevacizumab injection
  • Chemotherapeutic Combinations

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov