Clinical trial · Interventional
PD-1 Inhibitor and Nab-paclitaxel and Bevacizumab in CUP
Phase 2, Open-label, Single Center, Prospective Study of Recombinant Humanized Anti-PD-1 Monoclonal Antibody Combined With Nab-paclitaxel and Bevacizumab in the Second-line Treatment of Patients With Cancer of Unknown Primary (CUP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial is a single-center, prospective, single-arm Phase II clinical study. The purpose is to evaluate the efficacy and safety of recombinant humanized anti-PD-1 monoclonal antibody combined with albumin paclitaxel and bevacizumab in the second-line treatment of patients with unknown primary tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Unknown Primary | Cancer of Unknown Primary, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant humanized anti-PD-1 monoclonal antibody injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Recombinant humanized anti-PD-1 monoclonal antibody injection:200mg once every 3 weeks
- interventionNames
- Drug: Recombinant humanized anti-PD-1 monoclonal antibody injection
Primary outcomes (1)
- measure
- objective response rate (ORR) was assessed using RECIST1.1 and IRECIST standards.
- timeFrame
- Approximately 24 months
- description
- ORR is defined as CR+PR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The histopathologically confirmed metastasis is adenocarcinoma, squamous cell carcinoma, poorly differentiated carcinoma, poorly differentiated malignant tumor or neuroendocrine carcinoma; 2. Patients whose primary lesions cannot be found after standard evaluation prior to treatment: detailed history, physical examination, blood test, chest and pelvic CT, PET/CT (optional), endoscopy of symptomatic sites, and pathological examination; 3. Measurable lesions (RECIST 1.1 criteria); 4. Patients who have progressed after receiving first-line treatment for Carcinoma of Unknown Primary. For example, those who have received paclitaxel or docetaxel in the first-line treatment and progressed more than three months after the end of last treatment; 5. ECOG of 0-2; 6. Life expectancy\>3 months; 7. Within 7 days (including 7 days) before screening, the laboratory test data requirements: neutrophil count ≥1.5×10\^9/L, platelet count ≥90×10\^9/L, hemoglobin ≥90g/L (No blood transfusion in 14 days), serum total bilirubin ≤1.25 times the upper limit of normal (ULN); ALT and AST≤2.5 x ULN (patients with liver metastases ≤5x ULN); serum creatinine ≤1.25 x ULN Exclusion Criteria: 1. Patients who have previously been treated with albumin paclitaxel or bevacizumab or PD-1 monoclonal antibody; 2. Received any experimental drugs or anti-tumor drugs within 4 weeks prior to enrollment; 3. A history of other tumors in the past 5 years, except for cervix or basal cell carcinoma of the skin that has been cured; 4. Symptomatic brain or meningeal metastases (unless the patient receives treatment for\> 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms related to the tumor are stable at the time of entering the study). NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (1)
- DERIVEDZhang X, Zhao T, Xu M, Guo Y, Wang Q, Wang Y, Zhou L, Hu S, Xu Q, Hu X, Liu X, Luo Z. Anti-PD-1 plus nab-paclitaxel and bevacizumab for second-line treatment of cancer of unknown primary (Fudan CUP-002): a phase II trial. Nat Commun. 2026 May 9;17(1):6263. doi: 10.1038/s41467-026-72745-6. PMID 42103741