Clinical trial · Interventional
Testing TH-302, in Combination With Preoperative Chemoradiotherapy, in Esophageal Cancer.
A Phase I Trial Testing TH-302, a Tumor-selective Hypoxia-Activated Cytotoxic Prodrug, in Combination With Preoperative Chemoradiotherapy in Patients With Distal Esophageal and Esophago-gastric Junction Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 2 Phase 3 trials didn't meet their primary endpoint, so further development and testing of TH-302 is uncertain
Summary
Brief summary (as posted)
Open-label, single-center phase 1 study of an investigational agent TH-302 and standard chemoradiotherapy with a 3+3 dose escalation design through 3 dose levels.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| HX4 scan | Other | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
| TH-302 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- treatment
- description
- treatment arm: TH-302 pre-treatment day 4 and weekly during treatment. 5 x carboplatin and paclitaxel, radiotherapy: 23 x 1.8Gy HX4 scans day 1 and day 8,surgery 6-10 weeks after chemo-radiotherapy
- interventionNames
- Drug: TH-302
- Other: HX4 scan
- Drug: Carboplatin
- Drug: Paclitaxel
- Radiation: Radiotherapy
- Procedure: surgery
Primary outcomes (1)
- measure
- Dose Limiting Toxicity (DLT )
- timeFrame
- within 30days postoperative
- description
- To determine the DLT and define the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma of the esophagus * Age \>18 years * UICC T2-4 N0-2 M0, potentially resectable disease * Patient discussed at tumour board (multidisciplinary team meeting) * No evident tumor invasion in nearby regions like aorta or trachea * WHO performance status 0-2 * Less than 10 % weight loss in the past 6 months * Laboratory requirements within 7 days prior to enrollment (start chemoradiotherapy): * Haematology: * haemoglobin \>10g/dl * absolute neutrophils ≥ 1.5 x 109/L * platelets ≥ 100x109/L * Biochemistry: * bilirubin within institutional normal limits * AST(SGOT)/ALT (SGPT) ≤ 2.5 institutional upper limit * Creatinine clearance ≥ 60 ml/min * Willing and able to comply with the study prescriptions * No history of prior thoracic radiotherapy * No severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia * Women should not be pregnant or lactating * No known infection with HIV, hepatitis B or C or any other active infection * Normal ECG with careful evaluation of QT/QTc * Have given written informed consent before patient registration Exclusion Criteria: * Recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction) * Patients with difficult peripheral intravenous access * History of prior thoracic radiotherapy * severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia * Women who are pregnant or lactating * Known infection with HIV, hepatitis B or C or any other active infection
References
Publications (1)
- DERIVEDLarue RT, Van De Voorde L, Berbee M, van Elmpt WJ, Dubois LJ, Panth KM, Peeters SG, Claessens A, Schreurs WM, Nap M, Warmerdam FA, Erdkamp FL, Sosef MN, Lambin P. A phase 1 'window-of-opportunity' trial testing evofosfamide (TH-302), a tumour-selective hypoxia-activated cytotoxic prodrug, with preoperative chemoradiotherapy in oesophageal adenocarcinoma patients. BMC Cancer. 2016 Aug 17;16:644. doi: 10.1186/s12885-016-2709-z. PMID 27535748