Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2/3NCT06841679

Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2/3 study testing Utidelone Capsule, Fluoropyrimidine- and Platinum-containing Therapy and Oxaliplatin in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 10 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a multi-national, open-label, randomized, seamless phase II/III clinical study of UTD2 combined with fluoropyrimidine- and platinum-containing therapy to evaluate the efficacy and safety in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma untreated with systemic… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastric or Gastroesophageal Junction Adenocarcinoma
What is being tested?: Utidelone Capsule, Fluoropyrimidine- and Platinum-containing Therapy and Oxaliplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 778 participants
Where: 10 sitesin 2 countries
Study dates: 28 Aug 2025to 1 Sep 2030
Phase: Phase 2/3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must meet the following criteria to be eligible for the study:
Sign the informed consent form (ICF) to participate with accordance with GCP, ICH and local regulations and are willing to adhere to the study protocol.
Male and female aged ≥ 18 years as of the date of baseline visit.
Participant must have unresectable locally advanced or metastatic GC or GEJ and have histologically/pathologic confirmed predominant adenocarcinoma. The documentation of GEJ involvement can include biopsy, endoscopy, or imaging.
Phase II Study: No restriction on PD-L1 expression. Phase III study: Participant must have tumor with PD-L1 Combined Positive Score (CPS) < 1 by immunohistochemical (IHC). IHC results from site are acceptable.
Participant must have at least one measurable lesion per RECIST 1.1 criteria.

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Participant must not receive previously systemic treatment in the advanced setting. Previously neoadjuvant/adjuvant therapy for GC or GEJ with no progression after 6 months from completion is allowed. Palliative radiotherapy is allowed.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Participant with adequate hematological function (CTCAE v5.0 Grade ≤ 1) within 1 week before enrollment (based on routine laboratory values at each site) and who have not received recombinant human granulocyte colony-stimulating factor (rhG-CSF) or blood products/erythropoietin (EPO) within 14 days before enrollment.
White blood cell count (WBC) ≥ 3.0 × 109/L;
Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
Platelet count (PLT) ≥ 100 × 109/L;
Hemoglobin (Hb) ≥ 9.0 g/dL.
Participant with adequate liver and renal function (CTCAE v5.0 Grade ≤ 1) within 1 week before enrollment (based on routine laboratory values at each site).
Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN);
Alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatic metastases);
Aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN in patients with hepatic metastases);
Creatinine clearance (Ccr) ≥ 50 mL/min.
Female Participants of childbearing potential must agree to use highly effective contraceptive methods during the study and within 6 months after the last dose of the investigational product. Female patients of childbearing potential shall have a negative serum or urine pregnancy test at screening and be willing to have additional pregnancy tests as required throughout the study. Women of non-childbearing potential (WONCBP) must not donate ova from signing informed consent until at least 6 months after the last administration of the investigational product. Please refer to Appendix 1. Males must be surgically sterile (> 6 months since vasectomy with confirmation of no viable sperm), or if engaged in sexual relations (intercourse) with a WOCBP, either his partner must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method must be used from Screening until 6 months after last IMP administration; or Males with same-sex partners (abstinence from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle; or Males must not donate sperm from the first dose of IMP until at least 90 days after the last dose of IMP.

Who cannot join

Participants will be excluded from the study for any of the following reasons:
Known HER2-positive tumor (HER2-positive is defined as having an IHC score of 3 +, or IHC2 + and positive HER2 expression by in situ hybridization (ISH) (refer to ASCO/CAP guidelines 2020).
Participants with other malignancies over the past 5 years, except for cured skin basal cell carcinoma, in-situ carcinoma of the cervix, or papillary thyroid cancer.
Participants who have received radiotherapy or other investigational drug or investigational therapy within 4 weeks prior to the first dose of investigational product.
Participants who have undergone major surgery (except biopsy) had significant trauma within 4 weeks prior to the first dose of investigational product or required elective surgery during the study.
Participants with pre-existing > Grade 1 peripheral sensory neuropathy (NCI CTCAE 5.0).

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Participants with known hypersensitivity to any components of the investigational product.
Participants who are pregnant (positive pregnancy test) or lactating.
Adverse events due to previous anti-tumor therapy have not recovered to CTCAE v5.0 Grade ≤ 1 (except for alopecia and other toxicities judged by the investigator to have no safety risk).
Participants with esophageal obstruction, pyloric obstruction, intestinal obstruction, or inability to eat on their own after gastrointestinal resection, or other factors that cause difficulty swallowing and inability to take oral drugs.
Participants with symptomatic/uncontrollable central nervous system metastases or meningeal metastases, including but not limited to those with confirmed metastatic disease progression by examination within 2 months after radiotherapy or other local treatment, or who are ineligible for enrollment as judged by the investigator.
Participants with uncontrollable bone metastases, i.e., existing or recent fracture risk, recent need for surgery or local radiotherapy, or other crisis conditions as judged by the investigator.
Participants with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once monthly or more frequently).
Participants with an active infection and who currently require systematic anti-infective therapy.
Participants with known history of human immunodeficiency virus (HIV) infection with an exception that if they have not had an opportunistic infection within the past 12 months, they are eligible.
Participants who are HBV DNA positive or HCV RNA positive (who are HBsAg negative, or HCV antibody negative could be eligible without testing for HBV DNA or HCV RNA).
Participants with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
Patients with severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention or second/third-degree atrioventricular block; patients with a mean corrected QT interval (QTcF) > 470 msec obtained from three 12-lead electrocardiograms (ECGs) at rest.
Patients who have had an acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥ 3 cardio-cerebrovascular events within 3 months before the first dose.
Patients with clinically uncontrollable hypertension.
Symptomatic Cerebral Infarction
Patients with other cardiac disorders that put the patients at a high risk as judged by the investigator.
Participants with uncontrolled diabetes mellitus.
Participants with a mental disorder or poor compliance.
Participants also participate in another interventional clinical study or receive other study treatments (patients who have discontinued other investigational treatments and are only in the follow-up period are allowed to be enrolled in this study).
Participants requiring concomitant use of strong CYP3A4 inhibitors or inducers or medications that prolong the QT interval within 14 days prior to the first dose of study treatment and during the study.
Participants with a history of other systemic severe diseases or abnormal laboratory findings that would, in the Investigator's judgment, be inappropriate for this study.

Trial locations and contacts

10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Rongguo Qiu contact

010-56315388

Rqiu2001@yahoo.com

Country

City, postcode or hospital

Sites recruiting now only

10 sites in 2 countries

China9 sites, 9 recruiting

AnYang Tumor Hospital
Anyang
Jin Xia
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Ruihua Xu
Recruiting
Jinan Municipal Central Hospital
Jinan
Meili Sun
Recruiting
Shandong First Medical University Affiliated Tumor Hospital
Jinan
Bo Liu
Recruiting
Liaoning Cancer Hospital
Shenyang
Jingdong Zhang
Recruiting
Shanxi Cancer Hospital
Taiyuan
Wenhui Yang
Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Ting Deng
Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Xianglin Yuan
Not yet recruiting
Henan Cancer Hospital
Zhengzhou
Jufeng Wang
Recruiting

Other trials in China

United States1 site, 1 recruiting

Bioresearch Partner
Hialeah, Florida, 33013
Luis Rangel
Not yet recruiting

Other trials in United States

About this study

Official title: A Multi-national, Open-label, Randomized Phase II/III Clinical Study of Utidelone Capsule (UTD2) Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma
Being tested: Utidelone Capsule, Fluoropyrimidine- and Platinum-containing Therapy, Oxaliplatin, PD-1 inhibitor, Capecitabine
Keywords: UTD2, GC, GEJ

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Utidelone CapsuleDrug
UTD2 40 mg/m2/d, po, qd, day 1-5, q3w
Utidelone CapsuleDrug
50 mg/m2/d, po, qd, day 1-5, q3w
Utidelone CapsuleDrug
60 mg/m2/d, po, qd, day 1-5, q3w
Fluoropyrimidine- and Platinum-containing TherapyDrug
CAPOX: Capecitabine 1700 mg/m2/d, po, bid, d1-14，q3w, Oxaliplatin 130 mg/m2, iv, d1, q3w. After completing 6 times (18 weeks) of oxaliplatin treatment, the investigator may decide whether to continue oxaliplatin treatment for up to 8 times (24 weeks) based on the participant's benefits and safety.
FOLFOX: Oxaliplatin 85 mg/m2, iv, d1, q2w. Folinic Acid 400 mg/m2, iv, d1, q2w, 5-FU 400 mg/m2 IV bolus d1 then 5-FU 2400 mg/m2 IV infusion over 46 to 48 hours, q2w. After completing 9 times (18 weeks) of treatment with oxaliplatin combined with folinic acid and 5-FU, the investigator may decide whether to continue FOLFOX treatment for up to 12 times (24 weeks) based on the participant's benefits and safety.
OxaliplatinDrug
130 mg/m2/d, iv, day1, q3w, oxaliplatin will be given up to 6 cycles
Utidelone CapsuleDrug
UTD2 po, on d1-5, q3w (dose decided after the phase II)
PD-1 inhibitorDrug
Whether to combine a PD-1 inhibitor will depend on the locally approved indications for the PD-1 inhibitor. If the participant's condition meets the locally approved indications for PD-1 inhibitors, the investigator may determine, in accordance with clinical guidelines, that the participant is eligible to receive treatment with UTD2 combined with fluoropyrimidine- and platinum-containing therapy, with or without a PD-1 inhibitor.
If a PD-1 inhibitor is administered in combination, tislelizumab (200 mg), or pembrolizumab (200 mg), or nivolumab (360 mg), iv, day1, q3w. Alternatively, the investigator may select the dosage and administration cycle of other locally approved PD-1 inhibitors in accordance with the locally approved package inserts. The PD-1 inhibitor will be given up to 2 years.
CapecitabineDrug
Capecitabine 1700 mg/m2/d po, bid, d1-14，q3w
CapecitabineDrug
Capecitabine, 2000 mg/m2/d, po, bid, d1-14, q3w

Study groups in NCT06841679
Study group	Role	What they receive
Cohort 1	Experimental	UTD2 40 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab ) Receives: Drug: Utidelone Capsule; Drug: Fluoropyrimidine- and Platinum-containing Therapy; Drug: PD-1 inhibitor
Cohort 2	Experimental	UTD2 50 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab ) Receives: Drug: Utidelone Capsule; Drug: Fluoropyrimidine- and Platinum-containing Therapy; Drug: PD-1 inhibitor
Cohort 3	Experimental	UTD2 60 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab ) Receives: Drug: Utidelone Capsule; Drug: Fluoropyrimidine- and Platinum-containing Therapy; Drug: PD-1 inhibitor
Arm A	Experimental	UTD2 po, on d1-5, q3w (dose decided after the phase II) in combination with CAPOX Receives: Drug: Oxaliplatin; Drug: Utidelone Capsule; Drug: Capecitabine
Arm B	Active comparator	CAPOX Receives: Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability of UTD2 and capecitabine in combination with oxaliplatin in Phase II
dose limiting toxicity (DLT), defined as any toxicity meeting the criteria outlined in the protocol during Cycle 1 in a 21-days cycle
Measured: From Day 1 to Day 21
Overall Survival (OS)
From the first dosing until death (from any cause), follow-up began after the end of treatment
Measured: 12 months

Secondary outcomes (8)

Objective Response Rate (ORR)
Response rate is the proportion of evaluable patients who are evaluated as having a CR or PR.
Measured: 12 months
Progression Free Survival (PFS)
refers to the time from first dosing to the occurrence of tumor progression or death (whichever occurs first)
Measured: 12 months
Maximum (or peak) serum concentration (Cmax)
Cmax of Utidelone Capsule
Measured: 12 months
Time to peak drug concentration (Tmax)
Tmax of Utidelone Capsule
Measured: 12 months
the area under the concentration-time curve from dosing (time 0) to time t (AUC0-t)
the AUC0-t of Utidelone Capsule
Measured: 12 months
the area under the concentration-time curve from time zero to infinity (AUCinf)
the AUC0inf of Utidelone Capsule
Measured: 12 months
the time required for plasma concentration of a drug to decrease by 50% (t1/2)
the t1/2 of Utidelone Capsule
Measured: 12 months
Treatment-emergent Adverse Events (TEAE)
Adverse events (AEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event version 5.0 (CTCAE v5.0)
Measured: Until 28 days after the last dose of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20251 Sep 2030

First posted24 Feb 2025
Study start28 Aug 2025
Primary completion1 Sep 2030 (estimated)
Study completion1 Sep 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric or Gastroesophageal Junction AdenocarcinomaStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 778 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06841679
Sponsor's protocol ID: BG02-2404
Status last verified: Nov 2025
First submitted: 10 Feb 2025
Last updated: 25 Nov 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-national, Open-label, Randomized Phase II/III Clinical Study of Utidelone Capsule (UTD2) Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
ClinicalTrials.gov ID: NCT06841679
Acronym / sponsor ID: BG02-2404
Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma
Keywords: UTD2, GC, GEJ
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 778 participants (estimated)
Lead sponsor: Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 28 Aug 2025 (actual)
Primary completion: 1 Sep 2030 (estimated)
Study completion: 1 Sep 2030 (estimated)
First posted: 24 Feb 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Cohort 1	Experimental	Drug: Utidelone Capsule, Drug: Fluoropyrimidine- and Platinum-containing Therapy, Drug: PD-1 inhibitorUTD2 40 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )
Cohort 2	Experimental	Drug: Utidelone Capsule, Drug: Fluoropyrimidine- and Platinum-containing Therapy, Drug: PD-1 inhibitorUTD2 50 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )
Cohort 3	Experimental	Drug: Utidelone Capsule, Drug: Fluoropyrimidine- and Platinum-containing Therapy, Drug: PD-1 inhibitorUTD2 60 mg/m2/d, po, qd, d1-5, q3w combined with CAPOX/FOLFOX with or without a PD-1 inhibitor ( tislelizumab, or pembrolizumab, or nivolumab )
Arm A	Experimental	Drug: Oxaliplatin, Drug: Utidelone Capsule, Drug: CapecitabineUTD2 po, on d1-5, q3w (dose decided after the phase II) in combination with CAPOX
Arm B	Active comparator	Drug: Oxaliplatin, Drug: CapecitabineCAPOX

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Participants must meet the following criteria to be eligible for the study:

Key exclusion criteria (27 listed)

Participants will be excluded from the study for any of the following reasons:

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
Utidelone CapsuleUTD2 40 mg/m2/d, po, qd, day 1-5, q3w	Drug	Cohort 1
Utidelone Capsule50 mg/m2/d, po, qd, day 1-5, q3w	Drug	Cohort 2
Utidelone Capsule60 mg/m2/d, po, qd, day 1-5, q3w	Drug	Cohort 3
Fluoropyrimidine- and Platinum-containing TherapyCAPOX: Capecitabine 1700 mg/m2/d, po, bid, d1-14，q3w, Oxaliplatin 130 mg/m2, iv, d1, q3w. After completing 6 times (18 weeks) of oxaliplatin treatment, the investigator may decide whether to continue oxaliplatin treatment for up to 8 times (24 weeks) based on the participant's benefits and safety. FOLFOX: Oxaliplatin 85 mg/m2, iv, d1, q2w. Folinic Acid 400 mg/m2, iv, d1, q2w, 5-FU 400 mg/m2 IV bolus d1 then 5-FU 2400 mg/m2 IV infusion over 46 to 48 hours, q2w. After completing 9 times (18 weeks) of treatment with oxaliplatin combined with folinic acid and 5-FU, the investigator may decide whether to continue FOLFOX treatment for up to 12 times (24 weeks) based on the participant's benefits and safety.	Drug	Cohort 1, Cohort 2, Cohort 3
Oxaliplatin130 mg/m2/d, iv, day1, q3w, oxaliplatin will be given up to 6 cycles	Drug	Arm A, Arm B
Utidelone CapsuleUTD2 po, on d1-5, q3w (dose decided after the phase II)	Drug	Arm A
PD-1 inhibitorWhether to combine a PD-1 inhibitor will depend on the locally approved indications for the PD-1 inhibitor. If the participant's condition meets the locally approved indications for PD-1 inhibitors, the investigator may determine, in accordance with clinical guidelines, that the participant is eligible to receive treatment with UTD2 combined with fluoropyrimidine- and platinum-containing therapy, with or without a PD-1 inhibitor. If a PD-1 inhibitor is administered in combination, tislelizumab (200 mg), or pembrolizumab (200 mg), or nivolumab (360 mg), iv, day1, q3w. Alternatively, the investigator may select the dosage and administration cycle of other locally approved PD-1 inhibitors in accordance with the locally approved package inserts. The PD-1 inhibitor will be given up to 2 years.	Drug	Cohort 1, Cohort 2, Cohort 3
CapecitabineCapecitabine 1700 mg/m2/d po, bid, d1-14，q3w	Drug	Arm A
CapecitabineCapecitabine, 2000 mg/m2/d, po, bid, d1-14, q3w	Drug	Arm B

Primary outcome

Safety and tolerability of UTD2 and capecitabine in combination with oxaliplatin in Phase II
Time frame: From Day 1 to Day 21
dose limiting toxicity (DLT), defined as any toxicity meeting the criteria outlined in the protocol during Cycle 1 in a 21-days cycle
Overall Survival (OS)
Time frame: 12 months
From the first dosing until death (from any cause), follow-up began after the end of treatment

8 secondary outcomes

Objective Response Rate (ORR)
Time frame: 12 months
Progression Free Survival (PFS)
Time frame: 12 months
Maximum (or peak) serum concentration (Cmax)
Time frame: 12 months
Time to peak drug concentration (Tmax)
Time frame: 12 months
the area under the concentration-time curve from dosing (time 0) to time t (AUC0-t)
Time frame: 12 months
the area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: 12 months
the time required for plasma concentration of a drug to decrease by 50% (t1/2)
Time frame: 12 months
Treatment-emergent Adverse Events (TEAE)
Time frame: Until 28 days after the last dose of treatment

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 25 Nov 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.

Rongguo Qiu contact

010-56315388

Rqiu2001@yahoo.com

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China, United States. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Contact Rongguo Qiu (010-56315388, Rqiu2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of UTD2 and capecitabine in combination with oxaliplatin in Phase II (time frame: From Day 1 to Day 21). 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?

On the ClinicalTrials.gov record for NCT06841679.

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 25 Nov 2025.