Clinical trial · Interventional
Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma
Multicenter, Open-Label and Randomized Phase II Study to Evaluate Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients After Curative Resection of a Confirmed Gastric Adenocarcinoma Compared With Surgery Alone
NCT00352833CI-TRIAL-00000929completedPhase 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)
Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety, tolerability and feasibility and secondary on relevant efficacy parameters.
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 Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| catumaxomab | Drug | Catumaxomab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- safety and efficacy data
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Signed and dated informed consent
* Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
* Intended curative gastrectomy ('en-bloc´-R0-resection considering the standard D2-scheme)
* Serosal infiltration (T3/T4, N+/-, M0) confirmed by immediate section with histopathologic assessment during surgery
* Karnofsky index \>= 70
* Negative pregnancy blood test at screening in women with childbearing potential
Exclusion Criteria:
* Presence of distant metastases
* Macroscopic and microscopic residual tumor present after surgery
* State after pancreas resection or thoracotomy
* Exposure to prior cancer therapy or planned adjuvant chemo-or radiotherapy of the current gastric cancer
* Previous treatment with non-humanized mouse or rat monoclonal antibodies
* Known/suspected hypersensitivity to catumaxomab or similar antibodies
* Any cancer disease or any cancer treatments within the last 5 years
* Presence of constant immunosuppressive therapy
* Inadequate renal function (creatinine \> 1.5 x ULN)
* Inadequate hepatic function (AST or ALT \> 2.5 x ULN or bilirubin \>= 1.5 x ULN)
* Platelets \< 75000 cells/mm³; absolute neutrophil count \< 1500 cells/mm³
* Patient had a bowel obstruction within the last 30 days
* Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
* Presence of any acute or chronic systemic infection
* Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study
* Patient is an employee of any involved study investigator or any involved institution including the study sponsor
* Parallel participation in another clinical trial or previous participation in this study
* Treatment with another investigational product during this study or during the last 30 days prior to study startReferences
Publications (5)
- BACKGROUNDHeiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165. PMID 15906359
- BACKGROUNDRuf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526. PMID 11588051
- BACKGROUNDRiesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711. PMID 11410615
- BACKGROUNDZeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237. PMID 10901380
- BACKGROUNDZeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52. PMID 10415020