MA-CRC-II-016 SHR-1811
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
SHR-A1811 & Bevacizumab injection
DrugHER2 ADC
Chemotherapeutic Combinations
DrugFOLFIRI+BEV
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: SHR-A1811 combined with bevacizumabActive comparator 1 intervention
Group B: Chemotherapeutic CombinationsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
ORR
objective response rate
Time frame
The end of cycle 2 (each cycle is 21 days) for SHR-A1811+BEV group and the end of cycle 3 (each cycle is 14 days) for FOLFIRI+BEV groupSecondary outcomes
1
PFS
progression free survival
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months2
OS
overall survival
Time frame
From data of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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