A Phase 3 interventional study of GFH375 and Chemotherapy in Metastatic Pancreatic Cancer, sponsored by Genfleet Therapeutics (Shanghai) Inc.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Genfleet Therapeutics (Shanghai) Inc. · Phase 3, Interventional, and Treatment
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Among 629 studies in Pancreatic Neoplasms with a site in China — 334 open to participants now, 359 under way, 30 of them phase 3. Pancreatic Neoplasms · China.
Among the 629 studies in Pancreatic Neoplasms with a site in China, this one is the 56th largest by planned enrollment of the 507 interventional ones that give a count, is one of 84 that started in 2025, is one of 41 in phase 3, reaches primary completion later than 241 of the 358 other live ones, and was the 556th registered.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.
Browse Pancreatic Neoplasms studies →334 of the 629 studies in Pancreatic Neoplasms with a site in China are open now. Recruiting first, the newest first:
Jiangsu HengRui Medicine Co., Ltd. · Sites in China
Ages 18–70
Ningbo Medical Center Lihuili Hospital · Sites in China
Ages 18–85
West China Hospital · Sites in China
Ages 18–75
Genfleet Therapeutics (Shanghai) Inc. · Sites in China
Ages 18–80
Peking University Third Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
629 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 190 · Phase 2 246 · Phase 3 54 · Phase 4 8
First in 2001; this study’s year is marked. 84 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 320 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Median enrollment 58 across the 507 interventional studies, 220 across the 121 observational. Of the 112 that completed or were terminated, 12 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
135 of 629 have an industry lead sponsor. The 10 most frequent:
Genfleet Therapeutics (Shanghai) Inc. is the lead sponsor of 18 studies on the registry; 14 are open to participants now.
Genfleet Therapeutics (Shanghai) Inc. has 3 studies filed under Pancreatic Neoplasms — fewer than ten, so there is no comparison to draw.
101 of the studies in Pancreatic Neoplasms with a site in China that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06601283Phase 3Fudan UniversityVitamin C Plus Cordyceps to Chemotherapy Related Anemia in Pancreatic Cancer | 2026-11-22 |
| NCT05653453Phase 3Jiangsu Healthy Life Innovation Medical Technology Co., LtdClinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatment of Locally Advanced Pancreatic Cancer | 2026-12-25 |
| NCT06217042Phase 3Fudan UniversityHR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer | 2027-03-30 |
| NCT06953999Phase 3AkesoA Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer | 2027-05-14 |
| NCT06409429Phase 3Tianjin Medical University Cancer Institute and HospitalNimotuzumab Combined With GX as Postoperative Adjuvant Therapy in Pancreatic Cancer | 2027-05-30 |
Add all 101 to your calendar (.ics) → With an account.
Among the 629 studies in Pancreatic Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFH375, Oral tablets
Drug: GFH375
There are three chemotherapy regimens. If participants are randomized to the control group, they will receive the treatment as determined by the investigator.
Drug: Chemotherapy
The experimental group receives GFH375 monotherapy, QD, orally
The control group includes three treatment regimens: AG, nal-IRI + 5-FU/LV, and S-1. If participants are randomized to the control group, they will receive the treatment which is determined by the investigator.
Also known as: Irinotecan Hydrochloride Liposome Injection, Fluorouracil Injection, Calcium Folinate, Tegafur,Gimeracil and Oteracil Potassium Capsules, Gemcitabine Hydrochloride for Injection, Paclitaxel for Injection(Albumin Bound)
OS
Overall Survival
Time frame: Up to approximately 2 years
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR
Time frame: Up to approximately 2 years
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors
Time frame: Up to approximately 2 years
ORR
ORR assessed by investigators and BICR
Time frame: Up to approximately 2 years
DCR
DCRassessed by investigators and BICR
Time frame: Up to approximately 2 years
DoR
DoR assessed by investigators and BICR
Time frame: Up to approximately 2 years
TTR
TTR assessed by investigators and BICR
Time frame: Up to approximately 2 years
The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Time frame: Up to approximately 2 years
EORTC QLQ-C30 Score
Changes in EORTC QLQ-C30
Time frame: Up to approximately 2 years
EORTC QLQ-PAN26 Score
Changes in EORTC QLQ-PAN26 Scores
Time frame: Up to approximately 2 years
Plasma concentrations of GFH375
Plasma concentrations of GFH375
Time frame: Up to approximately 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jun 2027, 18 months after the start.
Of 84 phase 3 interventional studies under Pancreatic Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 77. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: KRAS G12D Inhibitor VS-7375
Genfleet Therapeutics (Shanghai) Inc. →