Clinical trial · Interventional
A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
A Multicenter, Randomized, Open-label, Active-controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in 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 |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nab-paclitaxel Plus Gemcitabine | Drug | — | UNRESOLVED |
| Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine | Drug | — | UNRESOLVED |
| Surufatinib with Nab-paclitaxel, and Gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
- interventionNames
- Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Nab-paclitaxel Plus Gemcitabine
- interventionNames
- Drug: Nab-paclitaxel Plus Gemcitabine
- type
- OTHER
- label
- Surufatinib with Nab-paclitaxel, and Gemcitabine
- interventionNames
- Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process; 2. Age range is 18-75 years old (inclusive); 3. Pancreatic cancer confirmed by histology or cytology; 4. Stage IV metastasis Pancreatic cancer patients; 5. Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer; 6. According to RECIST 1.1, there is at least one measurable lesion; 7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1; 8. Expected survival time ≥ 12 weeks; Exclusion Criteria: 1. Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose; 2. Presence of other malignancies in the past 5 years; 3. Received major surgical surgery within 4 weeks before the first dose; 4. Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose; 5. Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine; 6. Received strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose; 7. Use of immunosuppressive drugs within 4 weeks before first dose; 8. Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis; 9. Patients who currently have hypertension that cannot be controlled by medication;
References
Publications (0)
Data not yet available