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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

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

PD-1/PD-L1 inhibitors · 1 trial · 7 indications

Phase 2 1
NCT07339488Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell CarcinomaBorderline Resectable Carcinoma
ACTIVE NOT_RECRUITING43 Analytics
PHASE2ACTIVE NOT_RECRUITING
Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma
Borderline Resectable CarcinomaUnlock trial analytics

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 to 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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Frequently asked questions about PD-1/PD-L1 inhibitors

What is PD-1/PD-L1 inhibitors used for in Borderline Resectable Carcinoma?

PD-1/PD-L1 inhibitors are being studied for use in borderline resectable carcinoma, specifically in esophageal squamous cell carcinoma (ESCC). The treatment combines intestinal low-dose radiotherapy with immunochemotherapy to convert borderline resectable or unresectable tumors into resectable ones. This is an investigational approach currently in Phase 2 clinical development.

What does PD-1/PD-L1 inhibitors target?

PD-1/PD-L1 inhibitors target the PD-1/PD-L1 pathway, which is a key immune checkpoint involved in suppressing T-cell activation. By inhibiting this pathway, the drug aims to enhance the immune system's ability to attack cancer cells. This mechanism is being evaluated in the context of borderline resectable esophageal squamous cell carcinoma.

Who makes PD-1/PD-L1 inhibitors?

PD-1/PD-L1 inhibitors are being developed by BeOne Medicines Ltd., a company listed on the stock exchange under the ticker ONC. The company is conducting clinical trials to evaluate the drug's efficacy in treating borderline resectable carcinoma, specifically esophageal squamous cell carcinoma.

What phase is PD-1/PD-L1 inhibitors in?

PD-1/PD-L1 inhibitors are currently in Phase 2 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied in an active clinical trial that is not yet recruiting participants, with a planned enrollment of 43 patients.

What clinical trials is PD-1/PD-L1 inhibitors in?

PD-1/PD-L1 inhibitors are being evaluated in a Phase 2 clinical trial with the identifier NCT07339488. The trial is titled 'Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma' and is active but not recruiting. It is an uncontrolled, open-label study enrolling 43 patients in China.

Is PD-1/PD-L1 inhibitors the same as Tislelizumab?

PD-1/PD-L1 inhibitors are a class of drugs, and Tislelizumab is a specific PD-1 inhibitor that is being used in the clinical trial for this indication. The trial combines Tislelizumab with chemotherapy and radiotherapy. Therefore, Tislelizumab is one example of a PD-1/PD-L1 inhibitor, but the class includes other agents as well.