Becotatug Vedotin Plus PD-1 Monoclonal Antibody and Radiotherapy for Unresectable Locally Recurre… (NCT07555860) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Becotatug Vedotin Plus PD-1 Monoclonal Antibody and Radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
28 participantsStarted 2026-04-20
Plain-language summary
This exploratory clinical study will enroll patients with unresectable locally recurrent nasopharyngeal carcinoma to receive two cycles of becotatug vedotin plus a PD-1 monoclonal antibody, followed by sequential radiotherapy and PD-1 monoclonal antibody maintenance until disease progression or unacceptable toxicity. The study aims to evaluate the efficacy and safety of this treatment strategy.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Voluntarily participates in the study and provides written informed consent.
* Aged 18-70 years, male or non-pregnant female, with an expected survival of ≥3 months and an ECOG performance status of 0 or 1.
* Histologically or cytologically confirmed locally recurrent nasopharyngeal carcinoma, differentiated or undifferentiated carcinoma, corresponding to WHO type II or III, with clinical stage rT2-4N0-3M0, rIA-III according to the AJCC 9th edition.
* Recurrence occurring more than 12 months after completion of initial radiotherapy, with no systemic or local antitumor treatment during this interval.
* At least one measurable lesion according to RECIST v1.1.
* Hemoglobin ≥90 g/L, white blood cell count ≥4.0 × 10⁹/L, and platelet count ≥100 × 10⁹/L.
* Adequate liver function: total bilirubin \<2.0 × ULN; AST and ALT ≤2.5 × ULN in the absence of liver metastasis, or ALT or AST ≤3.0 × ULN in the presence of liver metastasis; ALP ≤1.5 × ULN, or ≤2 × ULN in the presence of liver metastasis; serum albumin ≥30 g/L.
* Adequate coagulation function: INR or PT and APTT ≤1.5 × ULN, except for patients receiving anticoagulant therapy, whose anticoagulation level should be within the therapeutic range. These laboratory parameters should be closely monitored by the investigator if the patient is receiving anticoagulant therapy.
* Adequate renal function, defined as serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min if serum creatinine is \>1.5 × ULN. Crea…
What they're measuring
1
Objective response rate
Timeframe: Baseline; end of 2 induction cycles (21 days/cycle); 8-12 weeks after radiotherapy; every 12 weeks through Month 24; then every 24 weeks thereafter until progression, new anticancer therapy, death, or study completion, up to 36months.