Clinical trial · Interventional
Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma
Phase II Trial of Raltitrexed and Paclitaxel as Second-line Chemotherapy for Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- 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 is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary endpoint of this study is objective response rate.The secondary endpoint of this study is safety,progression-free survival and overall survival.
Conditions
Conditions (2)
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 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Raltitrexed | Drug | Raltitrexed | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Raltitrexed and Paclitaxel
- description
- All patients receive the combination therapy of Raltitrexed and Paclitaxel for a maximum of 6 cycles Raltitrexed:3mg/m2,d1 Paclitaxel:80mg/m2,d1,d8, Eery 3 weeks
- interventionNames
- Drug: Raltitrexed
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 18-26 months
Secondary outcomes (2)
- measure
- Overall Survival
- timeFrame
- 18-26 months
- description
- From date of randomization until date of death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; * Patients failed first-line chemotherapy containing fluoropyrimidines and platinums; * ECOG (Eastern Cooperative Oncology Group)performance status 0-1; * At least 1 measurable lesion should be present（RECIST1.1） * Available Organ function: Neutrophils\>2g/L, Hemoglobin\>9g/L, Blood platelet \>100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)\<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)\<1.0 ULN; Cr \<1.0ULN * Signed informed consent. * Life expectancy ≥3 months; Exclusion Criteria: * Previous treatment with Raltitrexed or Paclitaxel; * Known history of allergic reaction to Raltitrexed or Paclitaxel; * Known brain metastases; * Pregnant or breast feeding women; * Severe diarrhea,intestinal obstruction; * other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix); * Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia; * Kown HIV infecton.
References
Publications (0)
Data not yet available