Pancreatic CancerPhase 4NCT07557394

A Prospective Non-randomized Controlled Interventional Study on the Effect of Shouhui Tongbian Capsules Combined With Pancreatin Enteric-coated Capsules on Pancreatic Exocrine Function in Patients After Curative Resection for Pancreatic Cancer

A Phase 4 study testing Shouhui Tongbian Capsules and Pancreatin Enteric-Coated Capsules in people with Pancreatic Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Exploratory evaluation comparing the addition of Shouhui Constipation Capsules to standard pancreatic enzyme therapy for improving exocrine pancreatic function in patients after pancreaticoduodenectomy. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pancreatic Cancer
What is being tested?: Shouhui Tongbian Capsules and Pancreatin Enteric-Coated Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: 1 May 2026to 30 Apr 2028
Phase: Phase 4
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

Age: 18-80 years old;
Pathologically confirmed pancreatic cancer and underwent pancreaticoduodenectomy(involved removing 50% of the pancreas, leaving 50% of the pancreas, ensuring balanced grouping);
Presence of EPI symptoms (such as steatorrhea) and/or constipation (Bristol type 1-2, with <3 bowel movements per week);
Have informed consent and be proficient in using smartphone apps;
Patients who are intended to receive treatment with either Daitong Capsules or Shouhui Tongbian Capsules, or both;
The patient's condition is stable and suitable for participation in this study, as confirmed by investigator;
Willing and able to follow the medication and follow-up plan specified in the study protocol, with an expected medication adherence rate of over 80%.

Who cannot join

Allergic to pancreatic enzyme (porcine-derived protein allergy) or any ingredient of Shouhui Tongbian Capsules;
Have a history of liver damage caused by Polygonum multiflorum;
Combined with intestinal obstruction, severe hepatic and renal insufficiency (Child-Pugh Class C, eGFR < 30 ml/min), etc;
Pregnant or lactating women;
Psychological cognitive impairment.
It is expected that the 12-weeks follow-up will not be completed.

About this study

Read the detailed description

Patients who have undergone pancreaticoduodenectomy often face severe digestive function impairment, including exocrine pancreatic insufficiency, delayed gastric emptying, abdominal distension, constipation, and diarrhea, which significantly affect their postoperative recovery and quality of life. Currently, postoperative digestive function management primarily relies on pancreatic enzyme replacement therapy (PERT). However, monotherapy with pancreatic enzymes has limited efficacy in improving complex postoperative gastrointestinal symptoms, and patient compliance is poor, with dose adjustments lacking individualized basis. Shouhui Tongbian Capsule, a traditional Chinese medicine, has the effects of nourishing yin, invigorating qi, moistening the intestines, and promoting defecation. It is clinically used for the treatment of functional constipation and postoperative abdominal distension, showing good therapeutic effects. Existing studies have shown that Shouhui Tongbian Capsule can significantly improve postoperative bowel sound recovery time and first flatus time, and enhance patients' quality of life.

Conditions: Pancreatic Cancer
Being tested: Shouhui Tongbian Capsules, Pancreatin Enteric-Coated Capsules
Keywords: pancreaticoduodenectomy, PD, Pancreatic exocrine function
Medical subject headings: Pancreatic Neoplasms

What participants receive

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

Shouhui Tongbian CapsulesDrug
Also called Pancreatin Enteric-Coated Capsules
Shouhui Tongbian Capsules are taken orally, 2 capsules per dose, 3 times daily;Pancreatin enteric-coated capsules are administered at the clinically conventional dosage; for a continuous period of 12 weeks.
Pancreatin Enteric-Coated CapsulesDrug
Pancreatin enteric-coated capsules are administered at the clinically conventional dosage,for a continuous period of 12 weeks.

Study groups in NCT07557394
Study group	Role	What they receive
experimental group	Experimental	Not described Receives: Drug: Shouhui Tongbian Capsules; Drug: Pancreatin Enteric-Coated Capsules
control group	Active comparator	Not described Receives: Drug: Pancreatin Enteric-Coated Capsules

What is being measured

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

Improvement effect on pancreatic exocrine function
Change in fecal elastase-1 concentration (μg/g) from baseline to Week 12
Measured: 12 weeks after treatment

Timeline

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

1 May 202630 Apr 2028

First posted29 Apr 2026
Study start1 May 2026 (estimated)
Primary completion30 Nov 2027 (estimated)
Study completion30 Apr 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pancreatic CancerStudies 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07557394
Sponsor's protocol ID: 20251210034657959
Status last verified: Apr 2026
First submitted: 22 Apr 2026
Last updated: 29 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Non-randomized Controlled Interventional Study on the Effect of Shouhui Tongbian Capsules Combined With Pancreatin Enteric-coated Capsules on Pancreatic Exocrine Function in Patients After Curative Resection for Pancreatic Cancer
ClinicalTrials.gov ID: NCT07557394
Acronym / sponsor ID: 20251210034657959
Conditions: Pancreatic Cancer
Keywords: pancreaticoduodenectomy, PD, Pancreatic exocrine function
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 1 May 2026 (estimated)
Primary completion: 30 Nov 2027 (estimated)
Study completion: 30 Apr 2028 (estimated)
First posted: 29 Apr 2026 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Drug: Shouhui Tongbian Capsules, Drug: Pancreatin Enteric-Coated Capsules
control group	Active comparator	Drug: Pancreatin Enteric-Coated Capsules

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age: 18-80 years old;
Pathologically confirmed pancreatic cancer and underwent pancreaticoduodenectomy(involved removing 50% of the pancreas, leaving 50% of the pancreas, ensuring balanced grouping);
Presence of EPI symptoms (such as steatorrhea) and/or constipation (Bristol type 1-2, with <3 bowel movements per week);
Have informed consent and be proficient in using smartphone apps;
Patients who are intended to receive treatment with either Daitong Capsules or Shouhui Tongbian Capsules, or both;

Key exclusion criteria (6 listed)

Allergic to pancreatic enzyme (porcine-derived protein allergy) or any ingredient of Shouhui Tongbian Capsules;
Have a history of liver damage caused by Polygonum multiflorum;
Combined with intestinal obstruction, severe hepatic and renal insufficiency (Child-Pugh Class C, eGFR < 30 ml/min), etc;
Pregnant or lactating women;
Psychological cognitive impairment.

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
Shouhui Tongbian CapsulesAlso: Pancreatin Enteric-Coated CapsulesShouhui Tongbian Capsules are taken orally, 2 capsules per dose, 3 times daily;Pancreatin enteric-coated capsules are administered at the clinically conventional dosage; for a continuous period of 12 weeks.	Drug	experimental group
Pancreatin Enteric-Coated CapsulesPancreatin enteric-coated capsules are administered at the clinically conventional dosage,for a continuous period of 12 weeks.	Drug	control group, experimental group

Primary outcome

Improvement effect on pancreatic exocrine function
Time frame: 12 weeks after treatment
Change in fecal elastase-1 concentration (μg/g) from baseline to Week 12

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 Apr 2026.

Related trials for Pancreatic Cancer

RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
Pancreatic Cancer, Renal Cell Cancer
Active, not recruitingPhase 3
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm
RecruitingPhase 2
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma

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.

The record lists no contact. Use the official record to reach the sponsor.

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 7 inclusion and 6 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Improvement effect on pancreatic exocrine function (time frame: 12 weeks after treatment). 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 NCT07557394.

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 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.