The combination of local consolidative therapy for oligometastases with systemic therapy offers the potential for clinical cure and significantly prolongs survival in a subset of patients with advanced metastatic disease. However, a considerable proportion of patients still do not benefit from this approach. Becotatug vedotin (MRG003) is an antibody-drug conjugate that carries the payload monomethyl auristatin E (MMAE), a microtubule inhibitor. MMAE has been shown to effectively enhance radiosensitivity in various preclinical tumor models, including head and neck squamous cell carcinoma, liver cancer, gastric cancer, pancreatic cancer, and lung cancer. Furthermore, multiple clinical studies have demonstrated the promising therapeutic potential of vicetuximab in EGFR-positive solid tumors. Based on this background, we plan to conduct a clinical study evaluating the combination of stereotactic body radiotherapy (SBRT) for oligometastases with investigator-selected systemic therapy and Becotatug vedotin (MRG003) in patients with EGFR-positive oligometastatic tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Becotatug vedotin was administered intravenously at a dose of 2.0 mg/kg every 3 weeks (Q3W).
All oligometastatic lesions will be treated with SBRT with curative intent. Radiation doses are determined based on published clinical studies
Systemic therapy /Standard of Care will be determined at the investigator's discretion, in accordance with clinical guidelines and individual patient characteristics.
The Fifth Affiliated Hospital,Sun Yat-sen University
Zhuhai, Guangdong, China
NOT_YET_RECRUITINGThe Fifth Affiliated Hospital,Sun Yat-sen University
Zhuhai, Guangdong, China
RECRUITINGProgression-free Survival (PFS)
Defined as time from randomization to loco-regional or distant metastasis relapse or death from any cause, whichever occurred first.
Time frame: 1 year
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Time frame: 1 year
Objective Response Rate (ORR)
Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1.
Time frame: 3 months after SBRT
Disease Control Rate (DCR)
Defined as the proportion of patients whose tumors shrink to complete response (CR), partial response (PR) or stable disease (SD) and remain for a certain period of time according to RECIST 1.1.
Time frame: 3 months after SBRT
Duration of Response (DoR)
Defined as the time from the first documented Complete Response (CR) or Partial Response (PR) to the first documented disease progression (PD) or death from any cause in patients with an objective response
Time frame: 1 year
Health related quality of Life
The quality of life was evaluated by referring to the European EORTC Quality of Life Questionnaire Core 30 (QLQ-C30, version 3.0) . The scores range from 0 to 100, with higher scores indicating a better quality of life outcome and lower scores indicating worse symptoms or functions.
Time frame: Baseline, after every two cycles of systemic therapy, before SBRT, after SBRT, and at each follow-up.
Incidence of treatment related acute complications
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time frame: During systemic therapy and up to three months after SBRT
Incidence of treatment related late complications
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time frame: More than three months after SBRT
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