Metastatic or Recurrent Gastric AdenocarcinomaPhase 2NCT01396707
Trastuzumab in Combination With Capecitabine and Oxaliplatin(XELOX) in Patients With Advanced Gastric Cancer(AGC): Her+XELOX
A Phase 2 study testing Herceptin+XELOX in people with Metastatic or Recurrent Gastric Adenocarcinoma and Her-2 Positive Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This is an open-label, multicentre, prospective phase II trial designed to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic or Recurrent Gastric Adenocarcinoma, Her-2 Positive Gastric Cancer
- What is being tested?
- Herceptin+XELOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), assessed using imaging techniques (CT or MRI).
- HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2
- ECOG Performance status 0, 1 or 2
- Life expectancy of at least 3 months.
- Male or female. Age over 20 year.
- Signed informed consent.
Who cannot join
- Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platinum is not allowed).
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy tube).
- Patients with active (significant or uncontrolled) gastrointestinal bleeding.
- Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity over grade 2 NCI-CTCAE.
- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
- Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L.
Show all 23Show fewer
- Serum bilirubin > 1.5 × upper limit of normal (ULN); or, AST or ALT > 2.5 × ULN (or > 5 × ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 × ULN (or > 5 × ULN in patients with liver metastases, or > 10 × ULN in patients with bone but no liver metastases); or, albumin < 25 g/L.
- Creatinine clearance < 60 mL/min. Other Study Drug-Related Exclusion Criteria
- History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
- Baseline LVEF < 50% (measured by echocardiography or MUGA).
- Patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
- Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
- Clinically significant hearing abnormality.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- History or clinical evidence of brain metastases.
- Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- Positive serum pregnancy test in women of childbearing potential.
- Subjects with reproductive potential not willing to use an effective method of contraception.
- Received any investigational drug treatment within 4 weeks of start of study treatment.
- Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recovered from any acute toxicity).
- Major surgery within 4 weeks of start of study treatment, without complete recovery.
- History of HIV infection, Patients with known active infection with HBV, or HCV.
- Known hypersensitivity to any of the study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer
This is an open-label, multicentre, prospective phase II trial designed to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction.
Read the detailed description
Patients will be administered 6 cycles of combination chemotherapy, unless withdrawn earlier due to unacceptable toxicity, disease progression, or consent withdrawal. Patients will continue to be treated with trastuzumab alone until disease progression, unacceptable toxicity or consent withdrawal after finishing a maximum 6 cycles of combination chemotherapy.
- Being tested
- Herceptin+XELOX
- Keywords
- HER2, Trastuzumab, XELOX, PHASE 2
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herceptin+XELOXDrug
Also called Trastuzumab, Capecitabine, Oxaliplatin
Each 3-weekly cycle, with chemotherapy given for 6 cycles, and trastuzumab continued even after completion of the combination chemotherapy until disease progression
- Trastuzumab: 8 mg/kg i.v. loading dose on day 1, followed by 6 mg/kg i.v.infusion every 3 weeks
- Capecitabine: 1000 mg/m2 oral twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15)
- Oxaliplatin 130 mg/m2 i.v. on day 1
| Study group | Role | What they receive |
|---|---|---|
| Herceptin+XELOX | Experimental | Not described Receives: Drug: Herceptin+XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
To evaluate the overall response rate for patients treated with trastuzumab combinated with capecitabine plus oxaliplatin.
Measured: 1 year
Secondary outcomes (4)
Duration of response
Measured: 1 year
Time to progression
Measured: 1 year
Progression free survival
Measured: 1 year
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Metastatic or Recurrent Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Yoon-Koo Kang, Asan Medical Center
- Investigators
- Yoon-Koo Kang, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396707
- Sponsor's protocol ID
- AMC1101
- Status last verified
- Jan 2020
- First submitted
- 18 Jul 2011
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Parkin DM, Pisani P, Ferlay J. Global cancer statistics. CA Cancer J Clin. 1999 Jan-Feb;49(1):33-64, 1. doi: 10.3322/canjclin.49.1.33.
PubMed 10200776Murad AM, Santiago FF, Petroianu A, Rocha PR, Rodrigues MA, Rausch M. Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer. Cancer. 1993 Jul 1;72(1):37-41. doi: 10.1002/1097-0142(19930701)72:13.0.co;2-p.
PubMed 8508427Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997 Feb;8(2):163-8. doi: 10.1023/a:1008243606668.
PubMed 9093725Pyrhonen S, Kuitunen T, Nyandoto P, Kouri M. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer. 1995 Mar;71(3):587-91. doi: 10.1038/bjc.1995.114.
PubMed 7533517Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, et al. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer. 1993 Jun 15;71(12):3813-8. doi: 10.1002/1097-0142(19930615)71:123.0.co;2-5.
PubMed 8508349Ohtsu A, Shimada Y, Shirao K, Boku N, Hyodo I, Saito H, Yamamichi N, Miyata Y, Ikeda N, Yamamoto S, Fukuda H, Yoshida S; Japan Clinical Oncology Group Study (JCOG9205). Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol. 2003 Jan 1;21(1):54-9. doi: 10.1200/JCO.2003.04.130.
PubMed 12506170Mackean M, Planting A, Twelves C, Schellens J, Allman D, Osterwalder B, Reigner B, Griffin T, Kaye S, Verweij J. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol. 1998 Sep;16(9):2977-85. doi: 10.1200/JCO.1998.16.9.2977.
PubMed 9738566Kim TW, Kang YK, Ahn JH, Chang HM, Yook JH, Oh ST, Kim BS, Lee JS. Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced gastric cancer. Ann Oncol. 2002 Dec;13(12):1893-8. doi: 10.1093/annonc/mdf323.
PubMed 12453857Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr;20(4):666-73. doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19.
PubMed 19153121Mamenta EL, Poma EE, Kaufmann WK, Delmastro DA, Grady HL, Chaney SG. Enhanced replicative bypass of platinum-DNA adducts in cisplatin-resistant human ovarian carcinoma cell lines. Cancer Res. 1994 Jul 1;54(13):3500-5.
PubMed 8012973Schmidt W, Chaney SG. Role of carrier ligand in platinum resistance of human carcinoma cell lines. Cancer Res. 1993 Feb 15;53(4):799-805.
PubMed 8428361Andre T, Bensmaine MA, Louvet C, Francois E, Lucas V, Desseigne F, Beerblock K, Bouche O, Carola E, Merrouche Y, Morvan F, Dupont-Andre G, de Gramont A. Multicenter phase II study of bimonthly high-dose leucovorin, fluorouracil infusion, and oxaliplatin for metastatic colorectal cancer resistant to the same leucovorin and fluorouracil regimen. J Clin Oncol. 1999 Nov;17(11):3560-8. doi: 10.1200/JCO.1999.17.11.3560.
PubMed 10550155Royce ME, Hoff PM, Pazdur R. Progress in colorectal cancer chemotherapy: how far have we come, how far to go? Drugs Aging. 2000 Sep;17(3):201-16. doi: 10.2165/00002512-200017030-00004.
PubMed 11043819Eriguchi M, Nonaka Y, Yanagie H, Yoshizaki I, Takeda Y, Sekiguchi M. A molecular biological study of anti-tumor mechanisms of an anti-cancer agent Oxaliplatin against established human gastric cancer cell lines. Biomed Pharmacother. 2003 Nov;57(9):412-5. doi: 10.1016/s0753-3322(03)00027-1.
PubMed 14652166Cassidy J, Misset JL. Oxaliplatin-related side effects: characteristics and management. Semin Oncol. 2002 Oct;29(5 Suppl 15):11-20. doi: 10.1053/sonc.2002.35524.
PubMed 12422304
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01396707
- Acronym / sponsor ID
- AMC1101
- Keywords
- HER2, Trastuzumab, XELOX, PHASE 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jun 2011 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicentre, prospective phase II trial designed to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin as first-line therapy in patients with recurrent and/or metastatic HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction.
Detailed description
Patients will be administered 6 cycles of combination chemotherapy, unless withdrawn earlier due to unacceptable toxicity, disease progression, or consent withdrawal. Patients will continue to be treated with trastuzumab alone until disease progression, unacceptable toxicity or consent withdrawal after finishing a maximum 6 cycles of combination chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herceptin+XELOX | Experimental | Drug: Herceptin+XELOX |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
- Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), assessed using imaging techniques (CT or MRI).
- HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2
- ECOG Performance status 0, 1 or 2
- Life expectancy of at least 3 months.
Key exclusion criteria (23 listed)
- Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platinum is not allowed).
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy tube).
- Patients with active (significant or uncontrolled) gastrointestinal bleeding.
- Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity over grade 2 NCI-CTCAE.
- Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herceptin+XELOXAlso: Trastuzumab, Capecitabine, OxaliplatinEach 3-weekly cycle, with chemotherapy given for 6 cycles, and trastuzumab continued even after completion of the combination chemotherapy until disease progression * Trastuzumab: 8 mg/kg i.v. loading dose on day 1, followed by 6 mg/kg i.v.infusion every 3 weeks * Capecitabine: 1000 mg/m2 oral twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15) * Oxaliplatin 130 mg/m2 i.v. on day 1 | Drug | Herceptin+XELOX |
Primary outcome
Overall response rate
Time frame: 1 year
To evaluate the overall response rate for patients treated with trastuzumab combinated with capecitabine plus oxaliplatin.
4 secondary outcomes
Duration of response
Time frame: 1 year
Time to progression
Time frame: 1 year
Progression free survival
Time frame: 1 year
Overall survival
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Background: PubMed 10200776Parkin DM, Pisani P, Ferlay J. Global cancer statistics. CA Cancer J Clin. 1999 Jan-Feb;49(1):33-64, 1. doi: 10.3322/canjclin.49.1.33.
- Background: PubMed 8508427Murad AM, Santiago FF, Petroianu A, Rocha PR, Rodrigues MA, Rausch M. Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer. Cancer. 1993 Jul 1;72(1):37-41. doi: 10.1002/1097-0142(19930701)72:13.0.co;2-p.
- Background: PubMed 9093725Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997 Feb;8(2):163-8. doi: 10.1023/a:1008243606668.
- Background: PubMed 7533517Pyrhonen S, Kuitunen T, Nyandoto P, Kouri M. Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer. Br J Cancer. 1995 Mar;71(3):587-91. doi: 10.1038/bjc.1995.114.
- Background: PubMed 8508349Kim NK, Park YS, Heo DS, Suh C, Kim SY, Park KC, Kang YK, Shin DB, Kim HT, Kim HJ, et al. A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer. 1993 Jun 15;71(12):3813-8. doi: 10.1002/1097-0142(19930615)71:123.0.co;2-5.
- Background: PubMed 12506170Ohtsu A, Shimada Y, Shirao K, Boku N, Hyodo I, Saito H, Yamamichi N, Miyata Y, Ikeda N, Yamamoto S, Fukuda H, Yoshida S; Japan Clinical Oncology Group Study (JCOG9205). Randomized phase III trial of fluorouracil alone versus fluorouracil plus cisplatin versus uracil and tegafur plus mitomycin in patients with unresectable, advanced gastric cancer: The Japan Clinical Oncology Group Study (JCOG9205). J Clin Oncol. 2003 Jan 1;21(1):54-9. doi: 10.1200/JCO.2003.04.130.
- Background: PubMed 9738566Mackean M, Planting A, Twelves C, Schellens J, Allman D, Osterwalder B, Reigner B, Griffin T, Kaye S, Verweij J. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol. 1998 Sep;16(9):2977-85. doi: 10.1200/JCO.1998.16.9.2977.
- Background: PubMed 12453857Kim TW, Kang YK, Ahn JH, Chang HM, Yook JH, Oh ST, Kim BS, Lee JS. Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced gastric cancer. Ann Oncol. 2002 Dec;13(12):1893-8. doi: 10.1093/annonc/mdf323.
- Background: PubMed 19153121Kang YK, Kang WK, Shin DB, Chen J, Xiong J, Wang J, Lichinitser M, Guan Z, Khasanov R, Zheng L, Philco-Salas M, Suarez T, Santamaria J, Forster G, McCloud PI. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol. 2009 Apr;20(4):666-73. doi: 10.1093/annonc/mdn717. Epub 2009 Jan 19.
- Background: PubMed 8012973Mamenta EL, Poma EE, Kaufmann WK, Delmastro DA, Grady HL, Chaney SG. Enhanced replicative bypass of platinum-DNA adducts in cisplatin-resistant human ovarian carcinoma cell lines. Cancer Res. 1994 Jul 1;54(13):3500-5.
- Background: PubMed 8428361Schmidt W, Chaney SG. Role of carrier ligand in platinum resistance of human carcinoma cell lines. Cancer Res. 1993 Feb 15;53(4):799-805.
- Background: PubMed 10550155Andre T, Bensmaine MA, Louvet C, Francois E, Lucas V, Desseigne F, Beerblock K, Bouche O, Carola E, Merrouche Y, Morvan F, Dupont-Andre G, de Gramont A. Multicenter phase II study of bimonthly high-dose leucovorin, fluorouracil infusion, and oxaliplatin for metastatic colorectal cancer resistant to the same leucovorin and fluorouracil regimen. J Clin Oncol. 1999 Nov;17(11):3560-8. doi: 10.1200/JCO.1999.17.11.3560.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic or Recurrent Gastric Adenocarcinoma
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
Recurrent or Metastatic Solid Tumors
Not yet recruitingObservational study
Zanidatamab Outcomes and Lived Experiences in Advanced HER2+ GEA
Esophageal Cancer, GastroEsophageal Cancer
RecruitingPhase 2
Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas
HER2-negative, Gastroesophageal Junction
RecruitingPhase 2
Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H/dMMR Gastric Cancer
Gastric / Gastroesophageal Junction Adenocarcinoma, MSI-H Cancer
Active, not recruitingPhase 2
Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer
Gastric Adenocarcinoma, Esophagus Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-Koo Kang, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Herceptin+XELOX in people with Metastatic or Recurrent Gastric Adenocarcinoma and Her-2 Positive Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01396707, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.