Advanced Digestive System TumorPhase 2CCGLC-018NCT07053150
A Prospective, Open-label, Exploratory Basket Trial to Evaluate the Efficacy and Safety of Sintilimab Combined With Pyrotinib ± Chemotherapy in Patients With Advanced Digestive System Tumors
A Phase 2 study testing Sintilimab, Pyrotinib and Optional Chemotherapy in people with Advanced Digestive System Tumor, run by Tongji Hospital at 1 site in China.
Trial summary
This is a prospective, open-label, exploratory, phase II basket clinical trial designed to evaluate the efficacy and safety of sintilimab in combination with pyrotinib with or without chemotherapy in patients with advanced HER2-positive digestive system malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Digestive System Tumor
- What is being tested?
- Sintilimab, Pyrotinib and Optional Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 1 Apr 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients with unresectable locally advanced T3-4 stage or M1 stage metastatic digestive system tumors confirmed by histology or cytology, including gastric cancer, colorectal cancer, hepatocellular carcinoma, biliary tract cancer and pancreatic cancer
- Patients who have not received systematic treatment in the past or whose disease has progressed or is intolerant after standard first-line treatment, and whose disease has progressed for more than 6 months after neoadjuvant therapy/whose last adjuvant therapy failed/who have completed (new) adjuvant therapy for less than 6 months from disease recurrence can be enrolled
- Histologically or cytologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH-amplified/NGS-confirmed) locally advanced or metastatic digestive system tumors (including gastric, colorectal, hepatocellular, biliary tract cancers)
- ECOG performance status 0-2
- At least one measurable lesion per RECIST 1.1 criteria
Show all 14Show fewer
- Adequate organ function:
- Hematologic: ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥9 g/dL
- Hepatic: Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN for liver metastases/HCC); albumin ≥28 g/L
- Renal: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min; urine protein <2+ (if ≥2+, 24-hour urine protein <1 g)
- Coagulation: INR ≤2.3 or PT prolongation ≤6 seconds
- Life expectancy ≥12 weeks
- Fertile patients must use effective contraception during treatment and for 6 months after last dose
- Willing and able to provide written informed consent
Who cannot join
- Previous treatment with any HER2-targeted therapy (e.g., trastuzumab)
- History of hematologic malignancies
- Pregnancy, lactation, or plans to become pregnant during study
- Last anticancer therapy ≤28 days prior to enrollment or unresolved toxicities from prior therapy
- Contraindications to immunotherapy including:
- History of organ transplantation
Show all 19Show fewer
- Severe autoimmune diseases
- Grade ≥4 immune-related adverse events from prior immunotherapy
- Uncontrolled active infections
- Use of systemic immunosuppressants (>10 mg/day prednisone equivalent) within 14 days
- Known hypersensitivity to PD-1 inhibitors, pyrotinib, or monoclonal antibodies
- Participation in other clinical trials within 3 months
- Symptomatic ascites, pleural or pericardial effusion requiring drainage
- Life-threatening bleeding events within 3 months or arterial/venous thrombosis within 6 months (except stable catheter-related thrombosis)
- History of pulmonary fibrosis, interstitial lung disease, or drug-related pneumonitis
- Active tuberculosis requiring treatment or treated within past year
- Major surgery within 4 weeks or unhealed surgical wounds
- Severe dysfunction of major organs (heart, lungs, liver, kidneys, CNS)
- Any other condition that may increase risk or interfere with study results as judged by investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital
Wuhan, Hubei, 430030
Ze-yang Ding, M.D., +86 13407156200, zyding@tjh.tjmu.edu.cn
Han Gao, +86 17730117747, gh1023606887@163.com
About this study
Official title: A Prospective, Open-label, Exploratory Basket Trial to Evaluate the Efficacy and Safety of Sintilimab Combined With Pyrotinib ± Chemotherapy in Patients With Advanced Digestive System Tumors (CCGLC-018)
This is a prospective, open-label, exploratory, phase II basket clinical trial designed to evaluate the efficacy and safety of sintilimab in combination with pyrotinib with or without chemotherapy in patients with advanced HER2-positive digestive system malignancies. Eligible patients include those with locally advanced unresectable or metastatic gastric, colorectal, hepatocellular, biliary tract, or pancreatic cancers. Patients will receive sintilimab and pyrotinib, with chemotherapy regimens selected at the investigator's discretion based on tumor type and clinical condition. The primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety.
Read the detailed description
Immunotherapy, particularly immune checkpoint inhibitors (ICIs), has significantly advanced the treatment landscape for various solid tumors, but many patients still fail to respond or develop resistance. Combining ICIs with targeted agents may overcome these limitations. Pyrotinib is a pan-ErbB irreversible tyrosine kinase inhibitor (TKI) with potent activity against HER2, which is overexpressed in multiple digestive tract cancers including gastric, colorectal, biliary tract, and pancreatic cancers.
This basket trial investigates the efficacy and safety of sintilimab (a PD-1 inhibitor) combined with pyrotinib, with or without chemotherapy, in HER2-positive digestive system tumors. Patients must meet HER2 positivity criteria via IHC, FISH/CISH, or NGS. The study uses a Bayesian adaptive design to independently evaluate efficacy across cancer subtypes.
Patients will receive sintilimab (200 mg IV every 3 weeks) and pyrotinib (400 mg orally daily). Chemotherapy is optional and tailored by tumor type, including regimens such as FOLFOX, GC, XELOX, or AG, among others.
Primary endpoint: ORR per RECIST 1.1. Secondary endpoints: PFS, DCR, OS, and treatment-related adverse events (TRAEs).
The total planned enrollment is approximately 80 patients, with flexible sample size adjustments based on interim Bayesian analysis within each tumor cohort. Exploratory objectives include biomarker analysis (e.g., PD-L1, TMB, HER2 amplification/mutation) and tumor microenvironment changes.
- Conditions
- Advanced Digestive System Tumor
- Being tested
- Sintilimab, Pyrotinib, Optional Chemotherapy
- Keywords
- Pyrotinib, Sintilimab, HER2-Positive Advanced digestive system tumors, HER2-positive tumors, Immunotherapy, Targeted therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called Anti-PD-1 Monoclonal Antibody
Dosage Form: Intravenous (IV) infusion Dosage: 200 mg Frequency: Every 3 weeks (Q3W) Duration: Until disease progression, unacceptable toxicity, or up to 2 years
PyrotinibDrug
Also called Pan-HER Tyrosine Kinase Inhibitor
Dosage Form: Oral tablet Dosage: 400 mg once daily (QD) Frequency: Continuous daily dosing Duration: Until disease progression or intolerable toxicity
Optional ChemotherapyDrug
- FOLFOX: Oxaliplatin 85 mg/m² IV Day 1, leucovorin 400 mg/m² IV Day 1, 5-FU 400 mg/m² IV bolus + 2400 mg/m² continuous infusion over 46h (Days 2-3)
- GEMOX: Gemcitabine 1000 mg/m² and oxaliplatin 100 mg/m² IV Day 1
- GC: Gemcitabine 1000 mg/m² and cisplatin 25 mg/m² IV on Days 1 and 8
- XELOX (CapeOX) Oxaliplatin 130 mg/m² IV Day 1, capecitabine 1000 mg/m² PO BID Days 1-14
- SOX: Oxaliplatin 130 mg/m² IV Day 1, S-1 PO BID Days 1-14 (dose based on BSA: <1.25 m² = 40 mg, 1.25-<1.5 m² = 50 mg, ≥1.5 m² = 60 mg)
- TS: Paclitaxel 80 mg/m² IV Days 1 and 8, S-1 as above
- mFOLFOX6: Same as FOLFOX; used primarily in colorectal cancer
- FOLFIRINOX: Leucovorin 400 mg/m², 5-FU (bolus + continuous), irinotecan 180 mg/m², oxaliplatin 85 mg/m² IV Day 1
- AG:
Nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² IV on Days 1 and 8
| Study group | Role | What they receive |
|---|---|---|
| HER2-Positive Gastric Cancer | Experimental | Patients with HER2-positive advanced or metastatic gastric cancer will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. The investigator may choose from XELOX, SOX, or TS regimens based on clinical evaluation. Receives: Drug: Sintilimab; Drug: Pyrotinib; Drug: Optional Chemotherapy |
| HER2-Positive Colorectal Cancer | Experimental | Patients with HER2-positive advanced or metastatic colorectal cancer will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. The recommended regimens include mFOLFOX6 or XELOX, at the investigator's discretion. Receives: Drug: Sintilimab; Drug: Pyrotinib; Drug: Optional Chemotherapy |
| HER2-Positive Hepatocellular Carcinoma | Experimental | Patients with HER2-positive advanced or unresectable hepatocellular carcinoma will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. Chemotherapy may include FOLFOX or interventional locoregional therapies, as appropriate. Receives: Drug: Sintilimab; Drug: Pyrotinib; Drug: Optional Chemotherapy |
| HER2-Positive Biliary Tract Cancer | Experimental | Patients with HER2-positive advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer) will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. Suggested regimens include GC (gemcitabine + cisplatin) or GEMOX. Receives: Drug: Sintilimab; Drug: Pyrotinib; Drug: Optional Chemotherapy |
| HER2-Positive Pancreatic Cancer | Experimental | Patients with HER2-positive advanced or metastatic pancreatic cancer will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. Optional chemotherapy regimens include FOLFIRINOX or AG (nab-paclitaxel + gemcitabine). Receives: Drug: Sintilimab; Drug: Pyrotinib; Drug: Optional Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST v1.1. Responses must be confirmed by repeat imaging ≥4 weeks (±7 days) after the initial documentation.
Measured: Up to 24 months.
Secondary outcomes (4)
Progression-Free Survival (PFS)
Time from initiation of treatment to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: Up to 36 months.
Disease Control Rate (DCR)
Proportion of patients who achieve CR, PR, or stable disease (SD) as the best overall response per RECIST v1.1.
Measured: Up to 24 months.
Overall Survival (OS)
Time from treatment initiation to death from any cause. Patients who are alive at the last follow-up will be censored at the date of last contact.
Measured: Up to 36 months.
Treatment-Related Adverse Events (TRAEs)
Incidence, severity, and type of treatment-related adverse events as assessed by NCI-CTCAE v5.0, including laboratory abnormalities and dose interruptions or discontinuations due to toxicity.
Measured: From first dose through 90 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion1 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Digestive System TumorStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ze-yang Ding, MD, Tongji Hospital
- Investigators
- Ze-yang Ding, M.D., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053150
- Sponsor's protocol ID
- 2025-S045
- Acronym
- CCGLC-018
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Exploratory Basket Trial to Evaluate the Efficacy and Safety of Sintilimab Combined With Pyrotinib ± Chemotherapy in Patients With Advanced Digestive System Tumors (CCGLC-018)
- ClinicalTrials.gov ID
- NCT07053150
- Acronym / sponsor ID
- CCGLC-018 / 2025-S045
- Conditions
- Advanced Digestive System Tumor
- Keywords
- Pyrotinib, Sintilimab, HER2-Positive Advanced digestive system tumors, HER2-positive tumors, Immunotherapy, Targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd., Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 1 Apr 2031 (estimated)
- First posted
- 8 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.
This is a prospective, open-label, exploratory, phase II basket clinical trial designed to evaluate the efficacy and safety of sintilimab in combination with pyrotinib with or without chemotherapy in patients with advanced HER2-positive digestive system malignancies. Eligible patients include those with locally advanced unresectable or metastatic gastric, colorectal, hepatocellular, biliary tract, or pancreatic cancers. Patients will receive sintilimab and pyrotinib, with chemotherapy regimens selected at the investigator's discretion based on tumor type and clinical condition. The primary endpoint is objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety.
Detailed description
Immunotherapy, particularly immune checkpoint inhibitors (ICIs), has significantly advanced the treatment landscape for various solid tumors, but many patients still fail to respond or develop resistance. Combining ICIs with targeted agents may overcome these limitations. Pyrotinib is a pan-ErbB irreversible tyrosine kinase inhibitor (TKI) with potent activity against HER2, which is overexpressed in multiple digestive tract cancers including gastric, colorectal, biliary tract, and pancreatic cancers.
This basket trial investigates the efficacy and safety of sintilimab (a PD-1 inhibitor) combined with pyrotinib, with or without chemotherapy, in HER2-positive digestive system tumors. Patients must meet HER2 positivity criteria via IHC, FISH/CISH, or NGS. The study uses a Bayesian adaptive design to independently evaluate efficacy across cancer subtypes.
Patients will receive sintilimab (200 mg IV every 3 weeks) and pyrotinib (400 mg orally daily). Chemotherapy is optional and tailored by tumor type, including regimens such as FOLFOX, GC, XELOX, or AG, among others.
Primary endpoint: ORR per RECIST 1.1. Secondary endpoints: PFS, DCR, OS, and treatment-related adverse events (TRAEs).
The total planned enrollment is approximately 80 patients, with flexible sample size adjustments based on interim Bayesian analysis within each tumor cohort. Exploratory objectives include biomarker analysis (e.g., PD-L1, TMB, HER2 amplification/mutation) and tumor microenvironment changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HER2-Positive Gastric Cancer | Experimental | Drug: Sintilimab, Drug: Pyrotinib, Drug: Optional ChemotherapyPatients with HER2-positive advanced or metastatic gastric cancer will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. The investigator may choose from XELOX, SOX, or TS regimens based on clinical evaluation. |
| HER2-Positive Colorectal Cancer | Experimental | Drug: Sintilimab, Drug: Pyrotinib, Drug: Optional ChemotherapyPatients with HER2-positive advanced or metastatic colorectal cancer will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. The recommended regimens include mFOLFOX6 or XELOX, at the investigator's discretion. |
| HER2-Positive Hepatocellular Carcinoma | Experimental | Drug: Sintilimab, Drug: Pyrotinib, Drug: Optional ChemotherapyPatients with HER2-positive advanced or unresectable hepatocellular carcinoma will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. Chemotherapy may include FOLFOX or interventional locoregional therapies, as appropriate. |
| HER2-Positive Biliary Tract Cancer | Experimental | Drug: Sintilimab, Drug: Pyrotinib, Drug: Optional ChemotherapyPatients with HER2-positive advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic cholangiocarcinoma, gallbladder cancer) will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. Suggested regimens include GC (gemcitabine + cisplatin) or GEMOX. |
| HER2-Positive Pancreatic Cancer | Experimental | Drug: Sintilimab, Drug: Pyrotinib, Drug: Optional ChemotherapyPatients with HER2-positive advanced or metastatic pancreatic cancer will receive sintilimab (200 mg IV, Q3W) and pyrotinib (400 mg PO, QD), with or without chemotherapy. Optional chemotherapy regimens include FOLFIRINOX or AG (nab-paclitaxel + gemcitabine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years
- Patients with unresectable locally advanced T3-4 stage or M1 stage metastatic digestive system tumors confirmed by histology or cytology, including gastric cancer, colorectal cancer, hepatocellular carcinoma, biliary tract cancer and pancreatic cancer
- Patients who have not received systematic treatment in the past or whose disease has progressed or is intolerant after standard first-line treatment, and whose disease has progressed for more than 6 months after neoadjuvant therapy/whose last adjuvant therapy failed/who have completed (new) adjuvant therapy for less than 6 months from disease recurrence can be enrolled
- Histologically or cytologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH-amplified/NGS-confirmed) locally advanced or metastatic digestive system tumors (including gastric, colorectal, hepatocellular, biliary tract cancers)
- ECOG performance status 0-2
Key exclusion criteria (19 listed)
- Previous treatment with any HER2-targeted therapy (e.g., trastuzumab)
- History of hematologic malignancies
- Pregnancy, lactation, or plans to become pregnant during study
- Last anticancer therapy ≤28 days prior to enrollment or unresolved toxicities from prior therapy
- Contraindications to immunotherapy including:
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 |
|---|---|---|
| SintilimabAlso: Anti-PD-1 Monoclonal AntibodyDosage Form: Intravenous (IV) infusion Dosage: 200 mg Frequency: Every 3 weeks (Q3W) Duration: Until disease progression, unacceptable toxicity, or up to 2 years | Drug | HER2-Positive Biliary Tract Cancer, HER2-Positive Colorectal Cancer, HER2-Positive Gastric Cancer, HER2-Positive Hepatocellular Carcinoma, HER2-Positive Pancreatic Cancer |
| PyrotinibAlso: Pan-HER Tyrosine Kinase InhibitorDosage Form: Oral tablet Dosage: 400 mg once daily (QD) Frequency: Continuous daily dosing Duration: Until disease progression or intolerable toxicity | Drug | HER2-Positive Biliary Tract Cancer, HER2-Positive Colorectal Cancer, HER2-Positive Gastric Cancer, HER2-Positive Hepatocellular Carcinoma, HER2-Positive Pancreatic Cancer |
| Optional Chemotherapy1. FOLFOX: Oxaliplatin 85 mg/m² IV Day 1, leucovorin 400 mg/m² IV Day 1, 5-FU 400 mg/m² IV bolus + 2400 mg/m² continuous infusion over 46h (Days 2-3) 2. GEMOX: Gemcitabine 1000 mg/m² and oxaliplatin 100 mg/m² IV Day 1 3. GC: Gemcitabine 1000 mg/m² and cisplatin 25 mg/m² IV on Days 1 and 8 4. XELOX (CapeOX) Oxaliplatin 130 mg/m² IV Day 1, capecitabine 1000 mg/m² PO BID Days 1-14 5. SOX: Oxaliplatin 130 mg/m² IV Day 1, S-1 PO BID Days 1-14 (dose based on BSA: <1.25 m² = 40 mg, 1.25-<1.5 m² = 50 mg, ≥1.5 m² = 60 mg) 6. TS: Paclitaxel 80 mg/m² IV Days 1 and 8, S-1 as above 7. mFOLFOX6: Same as FOLFOX; used primarily in colorectal cancer 8. FOLFIRINOX: Leucovorin 400 mg/m², 5-FU (bolus + continuous), irinotecan 180 mg/m², oxaliplatin 85 mg/m² IV Day 1 9. AG: Nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m² IV on Days 1 and 8 | Drug | HER2-Positive Biliary Tract Cancer, HER2-Positive Colorectal Cancer, HER2-Positive Gastric Cancer, HER2-Positive Hepatocellular Carcinoma, HER2-Positive Pancreatic Cancer |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 24 months.
Proportion of patients achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST v1.1. Responses must be confirmed by repeat imaging ≥4 weeks (±7 days) after the initial documentation.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 36 months.
Disease Control Rate (DCR)
Time frame: Up to 24 months.
Overall Survival (OS)
Time frame: Up to 36 months.
Treatment-Related Adverse Events (TRAEs)
Time frame: From first dose through 90 days after last dose.
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 8 Jul 2025.
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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.
Ze-yang Ding, M.D. study chair
Tongji Hospital
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 Sintilimab, Pyrotinib and Optional Chemotherapy in people with Advanced Digestive System Tumor, run by Tongji 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 14 inclusion and 19 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: opening soon, as of the sponsor's last update on 8 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?
Contact Ze-yang Ding, M.D. (+86 13407156200, zyding@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 24 months.). 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 8 Jul 2025.