Clinical trial · Interventional
Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
NCT04814485CI-TRIAL-00051965unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1020+albumin-bound paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1020 combined with albumin-bound paclitaxel
- description
- SHR-1020 combined with albumin-bound paclitaxel
- interventionNames
- Drug: SHR-1020+albumin-bound paclitaxel
Primary outcomes (1)
- measure
- ORR (Objective Response Rate)
- timeFrame
- From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months]
- description
- Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles.
Secondary outcomes (5)
- measure
- DCR (Disease Control Rate)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria. * Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy * ECOG score 0-2 * Adequate organ and bone marrow function * The expected survival time is ≥ 12 weeks * Had normal swallowing function, without dysfunction of gastrointestinal absorption * Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures Exclusion Criteria: * The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel; * The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy * Known to be allergic to the active ingredients or excipients in this study. * Had other active malignant tumors within 5 years before entering the study. * Subject with cerebral metastasis * Have a clear history of serious and uncontrolled other disease or mental disorders; * Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy * Other situations that the researcher considers inappropriate to participate in the research.
References
Publications (0)
Data not yet available
No reference posted for this study.