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OncoMatch/Clinical Trials/NCT06359275

PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients

Is NCT06359275 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including PD-1 and Nab-paclitaxel for pancreatic cancer.

Phase 2RecruitingFudan UniversityNCT06359275Data as of May 2026

Treatment: PD-1 · Nab-paclitaxel · GemcitabineThis trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Disease stage

Required: Stage III

Excluded: Stage DISTANT METASTASIS

locally advanced pancreatic adenocarcinoma ... or pancreatic cancer with only local recurrence but no distant metastasis after surgery

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-PD-1 therapy

Have received anti-PD-1 or anti-PD-L1 antibody treatment in the past

Cannot have received: anti-PD-L1 therapy

Have received anti-PD-1 or anti-PD-L1 antibody treatment in the past

Cannot have received: systemic therapy for locally advanced pancreatic cancer

Previous systemic treatment for locally advanced pancreatic cancer

Cannot have received: radiotherapy (upper abdomen)

Have received radiotherapy for the upper abdomen in the past

Cannot have received: investigational drug

Have received any investigational drugs within 4 weeks before using the investigational drugs for the first time

Cannot have received: experimental drug

Have received any experimental drug treatment or participated in another interventional clinical trial within 30 days of the screening period

Cannot have received: taxane-containing regimen (neoadjuvant/adjuvant)

Exception: only if pathologically diagnosed with squamous cell carcinoma (not limited to organs)

Subjects who have been pathologically diagnosed with squamous cell carcinoma (not limited to organs) and received taxane-containing regimens as neoadjuvant/adjuvant treatment

Lab requirements

Blood counts

ANC ≥1.5×10^9/L; PLT ≥80×10^9/L; Hb ≥90g/L

Kidney function

serum creatinine ≤ 1.5x ULN, or calculated creatinine clearance ≥ 50ml/min

Liver function

Total bilirubin (TBil) ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN (≤5x ULN if liver metastasis present)

Hematological dysfunction is defined as i) absolute neutrophil (ANC) count ≥1.5×109/L; ii) platelet (PLT) count: ≥80×109/L; iii) hemoglobin (Hb) level ≥ 90g/L. Abnormal liver function is defined as: i) Total bilirubin (TBil) level: ≤ 1.5 times the upper limit of normal (ULN); ii) Aspartate aminotransferase (AST) and alanine; aminotransferase (ALT) levels ≤ 2.5 times the ULN, if liver metastasis is present, ≤5 times ULN; Abnormal renal function definition: serum creatinine ≤ 1.5 times ULN, or calculated creatinine clearance ≥ 50ml/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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