Clinical trial · Interventional
SHR6390 Plus Nab-paclitaxel and Gemcitabine in Advanced/Metastatic Pancreatic Cancer
A Phase II Study of SHR6390 Plus Nab-paclitaxel and Gemcitabine in Unresectable Advanced/Metastatic Pancreatic Ductal Adenocarcinoma
NCT05185869CI-TRIAL-00055859unknownPhase 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)
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| SHR6390 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AG+SHR6390
- description
- Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine
- interventionNames
- Drug: SHR6390
- Drug: Nab-paclitaxel
- Drug: Gemcitabine
Primary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 2 years.
- description
- ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1.
- measure
- Adverse Events (AEs)
- timeFrame
- From the first drugs administration to within 30 days for the last treatment.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female of 18 to 75 years old; 2. Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion \> 10 mm); 3. Subjects are naïve to systemic treatment; 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 5. Life expectancy ≥12 weeks; 6. Adequate organ performance based on laboratory blood tests; 7. The toxicity of the previous treatment has been restored to ≤1 level (if there is surgery, the wound has completely healed); 8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation; 9. Normal swallowing function; 10. 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: 1. Had other active malignant tumors within 5 years before entering the study; 2. Confirmed or suspicious new metastatic lesion in brain; 3. Subjects are allergy to experimental drugs or any excipients; 4. Coagulation disorders (INR\>1.5, APTT\>ULN); 5. Severe pleural effusion or ascites; 6. Severe and uncontrolled medical diseases, acute infections; recent history of major surgery for myocardial infarction (within 3 months); 7. Subjects combined with other anti-tumor drugs; 8. Chronic diarrhea or intestinal obstruction; 9. Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures; 10. Subjects in any trial drug treatment; 11. Severe mental disorder; 12. Other situations that investigators considered should be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.