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This is a Phase 3, multicenter, randomized and double-blind study assessing the interchangeability between TRS003 and China-approved Bevacizumab® (also called China-approved Avastin) for first-line treatment of patients with metastatic Colorectal Cancer (CRC), approximately 126 patients will be enrolled in this study. Patients who sign the informed consent, meet the eligibility criteria and are confirmed as non-progressors after lead-in treatment period with Bevacizumab® in combination with modified FOLFOX6 chemotherapy for 6 cycles, will be randomized (1:1) to either the non-switching arm and receive Bevacizumab® + modified FOLFOX6 for all subsequent cycles or to the switching arm and receive TRS003 alternating with Bevacizumab® in combination with mFOLFOX6 until disease progression or intolerability.
Full description
This is a randomized, double-blind Phase 3 clinical trial evaluating the interchangeability, by a comparison of PK parameters between non-Switching and the Switching arms following the final switch between TRS003 and Bevacizumab® in patients with metastatic adenocarcinoma of the colon or rectum (please note that Bevacizumab® means China-approved Bevacizumab® in this protocol, unless otherwise specified). Approximately 126 patients will be enrolled in this study. Patients who sign the informed consent, meet the eligibility criteria and are confirmed as non-progressors after lead-in treatment period with Bevacizumab® in combination with modified FOLFOX6 chemotherapy for 6 cycles, will be randomized (1:1) to either the non-switching arm and receive Bevacizumab® + modified FOLFOX6 for all subsequent cycles or to the switching arm and receive TRS003 alternating with Bevacizumab® in combination with mFOLFOX6 until disease progression or intolerability. There will be 3 switches as detailed in the Treatment section (below) and the Schema. If oxaliplatin-induced neurotoxicity requires discontinuation of oxaliplatin, treatment will continue using leucovorin (LCV) plus 5-fluorouracil (5-FU) in combination with either Bevacizumab® or TRS003 until progressive disease (PD), intolerability, or other cause for stopping treatment.
Enrollment
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Inclusion criteria
Histologically documented adenocarcinoma of the colon or rectum
Must have radiographic documentation of measurable metastatic disease (per RECIST v1.1)
Patients with resected primary tumors are eligible if documented metastatic disease is present.
Age ≥ 18 years
ECOG Performance Status of 0-1
Patients who received oxaliplatin/fluorouracil-based adjuvant chemotherapy then developed metastatic disease are eligible if > 12 months since last adjuvant chemotherapy treatment. Consider biopsy to confirm lesions are metastatic colorectal cancer, especially if initial CRC was stage I.
May have received radiation with radio-sensitizing chemotherapy if completed > 12 months before enrollment. Patients with rectal cancer who have received locoregional radiation therapy are eligible if they have measurable metastatic disease that is outside the radiation therapy portal.
Patients with left or right sided primary colon cancers are eligible as are patients with RAS or BRAF mutant tumor (molecular determination is not required).
Hypertension must be well controlled (< 150/90) on a stable anti-hypertensive regimen.
Patients on full-dose anticoagulation or taking anti-platelet agents are eligible if on a stable dose of medication and have no active bleeding or conditions that predispose to bleeding.
For women of childbearing potential, must consent to use two highly effective methods (i.e., total abstinence, placement of an intrauterine device) of contraception during treatment and for an additional 90 days after the last administration of study drug.
Men with a partner of childbearing potential, must consent to use two highly effective methods of contraception during treatment and for an additional 90 days after the last administration of study drug.
Required laboratory values:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
126 participants in 2 patient groups
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Central trial contact
Hongwei Kang
Data sourced from clinicaltrials.gov
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