EFSPhase 2NCT07090031
Perioperative Treatment With TAS-102 in Combination With Oxaliplatin for Locally Advanced Rectal Cancer
A Phase 2 study testing TAS-102 in combination with oxaliplatin in people with EFS and pCR Rate, run by Qingdao Central Hospital at 1 site in China.
Trial summary
5-Fluorouracil (5-FU) based chemoradiotherapy is regarded a standard perioperative treatment in locally advanced rectal cancer, but the effective rate still low. We investigate oral TAS-102 plus oxaliplatin concurrent radiotherapy for stage II or III local advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- TAS-102 in combination with oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients are 18 years or older and have histologically confirmed adenocarcinoma of the rectum (defined as the distal border of the tumour less than 16 cm from the anal verge measured by rigid rectoscopy) with no evidence of distant metastases (identified by abdominal ultrasound or CT scan and chest radiography).
- Patients in the adjuvant cohort have undergone R0-resection by total mesorectal excision (TME) of a pT3-4 N any or T any N positive non-metastatic rectal cancer.
- Patients treated in the neoadjuvant cohort need to have a clinical T3-4 N any or T any N positive tumour staged by endoscopic ultrasound, provided the lower border of the tumour is located 0 - 16 cm from the anal verge measured by rigid rectoscopy and the primary tumour is deemed resectable by TME surgery on the basis of clinical assessment. Other eligibility criteria comprise: WHO status of zero or one; adequate liver, renal, and bone marrow function defined as follows: leucocyte count > 3,500/µl, thrombocyte count > 100,000/µl, hemoglobin > 10.0 g/dl; serum bilirubin < 2.0 mg/dl, serum creatinine < 2.0 mg/dl.
Who cannot join
- Prior treatment for rectal cancer, prior chemo- or immunotherapy, prior pelvic radiotherapy, or a history of other malignant diseases within the past five years with the exception of successfully treated basal carcinoma of the skin or carcinoma in situ of the uterine cervix.
- Participation in another trial, pregnancy, breast-feeding, unwillingness to use effective contraception, or a medical condition or concomitant illness which could potentially interfere with compliance to the protocol are regarded as exclusion criteria, as well.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Treatment With TAS-102 in Combination With Oxaliplatin for Locally Advanced Rectal Cancer: A Single-arm, One Center Study
5-Fluorouracil (5-FU) based chemoradiotherapy is regarded a standard perioperative treatment in locally advanced rectal cancer, but the effective rate still low. We investigate oral TAS-102 plus oxaliplatin concurrent radiotherapy for stage II or III local advanced rectal cancer.
- Being tested
- TAS-102 in combination with oxaliplatin
- Keywords
- TAS-102, Oxaliplatin, local advanced rectal cancer, concurrent chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102 in combination with oxaliplatinDrug
Induction : TAS102 35mg/m2, twice a day for 5 days, on 1st, 3rd, 5th week; Oxliplatin 85mg/m2 on 1st and 2nd week; Rectal radiotherapy 50GY/25f in 5 weeks. 2 weeks no treatment.
Consolidation: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 3 cycles. 4 weeks no treatment.
Surgery Adjuvant chemotherapy: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 16 cycles.
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 in combination with oxaliplatin and concurrent radiotherapy | Experimental | Not described Receives: Drug: TAS-102 in combination with oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pathalogical complete response rate
Measured: 24 monthss
pathologiccal complete response rate
tumor cell complete disappear pathologiccally
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EFSStudies of the same condition, open and under way.
- 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
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youxin Ji, Qingdao Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090031
- Sponsor's protocol ID
- KY202502802
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Treatment With TAS-102 in Combination With Oxaliplatin for Locally Advanced Rectal Cancer: A Single-arm, One Center Study
- ClinicalTrials.gov ID
- NCT07090031
- Acronym / sponsor ID
- KY202502802
- Keywords
- TAS-102, Oxaliplatin, local advanced rectal cancer, concurrent chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 29 Jul 2025 (actual)
- 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.
5-Fluorouracil (5-FU) based chemoradiotherapy is regarded a standard perioperative treatment in locally advanced rectal cancer, but the effective rate still low. We investigate oral TAS-102 plus oxaliplatin concurrent radiotherapy for stage II or III local advanced rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-102 in combination with oxaliplatin and concurrent radiotherapy | Experimental | Drug: TAS-102 in combination with oxaliplatin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible patients are 18 years or older and have histologically confirmed adenocarcinoma of the rectum (defined as the distal border of the tumour less than 16 cm from the anal verge measured by rigid rectoscopy) with no evidence of distant metastases (identified by abdominal ultrasound or CT scan and chest radiography).
Key exclusion criteria (2 listed)
- Prior treatment for rectal cancer, prior chemo- or immunotherapy, prior pelvic radiotherapy, or a history of other malignant diseases within the past five years with the exception of successfully treated basal carcinoma of the skin or carcinoma in situ of the uterine cervix.
- Participation in another trial, pregnancy, breast-feeding, unwillingness to use effective contraception, or a medical condition or concomitant illness which could potentially interfere with compliance to the protocol are regarded as exclusion criteria, as well.
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 |
|---|---|---|
| TAS-102 in combination with oxaliplatinInduction : TAS102 35mg/m2, twice a day for 5 days, on 1st, 3rd, 5th week; Oxliplatin 85mg/m2 on 1st and 2nd week; Rectal radiotherapy 50GY/25f in 5 weeks. 2 weeks no treatment. Consolidation: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 3 cycles. 4 weeks no treatment. Surgery Adjuvant chemotherapy: TAS102 35mg/m2, twice a day for 5 days, every 2 weeks, Oxliplatin 85 mg/m2, every 2 weeks a cycle, for total 16 cycles. | Drug | TAS-102 in combination with oxaliplatin and concurrent radiotherapy |
Primary outcome
pCR
Time frame: 24 monthss
pathalogical complete response rate
pathologiccal complete response rate
Time frame: 24 months
tumor cell complete disappear pathologiccally
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 TAS-102 in combination with oxaliplatin in people with EFS and pCR Rate, run by Qingdao Central Hospital at 1 site in China.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
pCR (time frame: 24 monthss). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2025.