Clinical trial · Interventional
Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer
Irinotecan Plus Thalidomide in Second Line Advanced Gastric Cancer : A Multicenter, Randomized, Controlled and Prospective Trial
- 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)
Recent clinical studies have demonstrated a reduction of irinotecan (CPT-11) gastrointestinal toxicities when the CPT-11 is administered in combination with thalidomide in patients with diagnosis of gastric cancer. The main purpose of this study is to investigate the efficacy and safety of thalidomide and CPT-11 in advanced gastric cancer. The investigators will also manage to find out the possible interactions between CPT-11 pharmacokinetics and thalidomide to explain the previously described gastrointestinal toxicity reduction.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CPT-11 | Drug | — | UNRESOLVED |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (thalidomide+CPT-11)
- description
- Patients will receive CPT-11 180 mg/m\^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles ,and oral thalidomide 100 mg/d qn. Maintenance therapy with thalidomide in the same dose is performed until disease progression.
- interventionNames
- Drug: Thalidomide
- Drug: CPT-11
- type
- EXPERIMENTAL
- label
- Arm B (CPT-11)
- description
- Patients will receive CPT-11 180 mg/m\^2 ivgtt ,over 90 minutes on day 1, every 21 days for one cycle, four cycles.
- interventionNames
- Drug: CPT-11
Primary outcomes (1)
- measure
- time to progression(TTP)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18y \<Age\<75y * Patients with histologically proven tumor focus will be eligible for this protocol * Measurable or assessable disease * At least 4 weeks since last chemotherapy ;chemotherapy regimens without Irinotecan * No hepatic, renal and hematopoietic dysfunction; no hemorrhage of digestive tract,obstructive jaundice, gastrointestinal perforation or obstruction * ECOG PS:0-2 * Expected OS ≥ 3 months Exclusion Criteria: * obstruction of digestive tract, thrombosis or other intolerant side effects during treatment
References
Publications (0)
Data not yet available