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PD-1/PD-L1 inhibitors

Phase 2

Borderline Resectable Carcinoma | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Jan 14, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07339488Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell CarcinomaPHASE2 ACTIVE NOT_RECRUITING 43Nov 1, 2025Nov 1, 2028Jan 14, 20261 China
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Study Endpoints
Primary Endpoints
Pathological Complete Response (pCR) Rate
From postoperative day 0 up to 15 weeks postoperatively.

The proportion of patients who, following conversion therapy, exhibit no residual invasive cancer cells in either the primary tumor site or regional lymph nodes upon pathological evaluation of surgical resection specimens, expressed as a percentage of the total treated population.

Secondary Endpoints
Major Pathological Response (MPR) Rate
From postoperative day 0 up to 15 weeks postoperatively.
Objective Response Rate (ORR)
Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months.
Disease Control Rate (DCR)
Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ILDR plus immunochemotherapy plus surgeryEXPERIMENTAL1Gy/1F ILDR + albumin-bound paclitaxel (3 cycles of 260 mg/m² on day 1), cisplatin (3 cycles of 75 mg/m² on day 1), and tislelizumab (3 cycles of 200 mg on day 1) + surgery
Interventions
NameTypeDescription
Intestinal Low Dose Radiotherapy-1GyRADIATION1Gy ILDR will be administered to patients in a single fraction. The radiation treatment volume composes both the jejunum and ileum.
PD-1/PD-L1 inhibitorsDRUG3 cycles of tislelizumab(200 mg D1 q3w)
ChemotherapyDRUG3 cycles of albumin-bound paclitaxel(260 mg/m2 D1 q3w)+ cisplatin(75 mg/m2 D1 q3w)
SurgeryPROCEDUREMcKeown esophagectomy or laparoscopic-assisted McKeown esophagectomy is recommended, with either two-and-a-half-field lymphadenectomy or three-field lymph node dissection.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients voluntarily enroll in this study, sign an informed consent form, and demonstrate good compliance. 2. Age ≥18 years and ≤75 years; both sexes are eligible. 3. ECOG performance status score of 0-1. 4. Pathologically confirmed esophageal squamous cell carcinoma (ESCC) p...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07339488studyFirstPostDate: changed