ClinicalTrials.gg
Active, not recruitingNCT07932951Updated Nov 12, 2026

Retrospective Analysis of a Psoralea Corylifolia (Buguzhi)-Containing TCM Formula for Gastrointestinal Cancers

An observational study in Esophageal Squamous Cell Carcinoma (ESCC), Gastric Cancer (GC) and Hepatocellular Carcinoma (HCC), sponsored by Peking University Cancer Hospital & Institute. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Peking University Cancer Hospital & Institute · Observational

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 401 studies in Esophageal Squamous Cell Carcinoma with a site in China — 174 open to participants now, 213 under way, 32 of them phase 3. Esophageal Squamous Cell Carcinoma · China.

Planned enrollment
31st of 50
120 · median 205
Started
2026
with 47 others
Observational
50 of 401
23 open now
Primary completion
2028-12
later than 186 of 212 live
Registered
401st of 401
by date

Among the 401 studies in Esophageal Squamous Cell Carcinoma with a site in China, this one is the 31st largest by planned enrollment of the 50 observational ones that give a count, is one of 48 that started in 2026, is one of 50 observational ones, reaches primary completion later than 186 of the 212 other live ones, and was the 401st registered.

Esophageal Squamous Cell Carcinoma

675 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.

Browse Esophageal Squamous Cell Carcinoma studies →

Open to participants now

174 of the 401 studies in Esophageal Squamous Cell Carcinoma with a site in China are open now. Recruiting first, the newest first:

169 more — sign in →

All 174 open studies →

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 →

Who these studies take

Of the 180 Esophageal Squamous Cell Carcinoma studies recruiting now, 83 (46%) set no upper age limit and 76 (42%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 401 studies in Esophageal Squamous Cell Carcinoma with a site in China, or all of them as a file.
02

Study summary

Psoralea corylifolia (Buguzhi) is a traditional Chinese medicine (TCM) herb with reported anti-tumor activity; its major bioactive compound, isobavachalcone (IBC), has been shown to inhibit ADORA3 and the downstream FAK/AKT/NF-κB signaling axis in gastrointestinal cancers. This is a retrospective, single-arm observational study reviewing medical records of approximately 120 patients with gastrointestinal cancers (esophageal squamous cell carcinoma, gastric cancer, hepatocellular carcinoma, and colorectal cancer; n=30 each) treated at Peking University Cancer Hospital who received TCM formulas containing Psoralea corylifolia as part of routine clinical care. The study evaluates changes in tumor response assessed by RECIST version 1.1 and in Karnofsky Performance Status (KPS) between baseline and 8-12 weeks after initiation of treatment.

Read the detailed description

Background: ADORA3 (adenosine receptor A3) is upregulated in several gastrointestinal cancers and correlates with poor prognosis. Isobavachalcone (IBC), a major bioactive chalcone isolated from Psoralea corylifolia, directly binds ADORA3, blocks intracellular Ca²⁺ mobilization, disrupts the calmodulin/focal adhesion kinase (FAK) complex, and inhibits FAK/AKT/NF-κB signaling, thereby suppressing oncogenic signaling and reprogramming the tumor immune microenvironment.

Study design and population: This is a retrospective, single-arm, case-series observational study reviewing medical records of patients with histologically confirmed gastrointestinal cancers (esophageal squamous cell carcinoma [ESCC], gastric cancer [GC], hepatocellular carcinoma [HCC], or colorectal cancer [CRC]) treated at Peking University Cancer Hospital who received TCM formulas containing Psoralea corylifolia (Buguzhi) as part of routine clinical care. Approximately 120 patients (30 per cancer type) with available baseline and post-treatment imaging and performance status records will be included.

Outcomes: The primary outcomes are (1) tumor response assessed by contrast-enhanced CT or MRI according to RECIST version 1.1 (CR/PR/SD/PD) and (2) change in Karnofsky Performance Status (KPS) score (improvement or deterioration defined as a change of ≥10 points), both measured at baseline and at 8-12 weeks after initiation of Buguzhi-containing TCM treatment.

Analysis and limitations: Concurrent anti-cancer treatments (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy) will be recorded and described, and exploratory subgroup analyses will be performed by cancer type and concurrent treatment. As a single-arm retrospective study without a control group, observed changes cannot be definitively attributed to Buguzhi-containing TCM formulas, and results will be interpreted as hypothesis-generating real-world evidence.

03

Conditions studied

  • Esophageal Squamous Cell Carcinoma (ESCC)
  • Gastric Cancer (GC)
  • Hepatocellular Carcinoma (HCC)
  • Colorectal Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with histologically confirmed gastrointestinal cancers (esophageal squamous cell carcinoma, gastric cancer, hepatocellular carcinoma, or colorectal cancer) treated at Peking University Cancer Hospital, who received Psoralea corylifolia-containing TCM formulas as part of routine clinical care, and have available imaging and clinical follow-up data.

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.

Inclusion criteria

  1. confirmed diagnosis of Gastrointestinal cancers, including esophageal squamous cell carcinoma, gastric cancer, hepatocellular carcinoma, or colorectal cancer.
  2. Received TCM formulas containing Psoralea corylifolia as part of routine clinical care.
  3. Available baseline and post-treatment imaging (CT or MRI) for 1.1 response assessment.
  4. Available performance status records before and after treatment.
  5. Complete clinicopathologic and follow-up data.

Exclusion criteria

Exclusion Criteria:

  1. Concurrent other active .
  2. Incomplete medical records or missing imaging data.
  3. Less than 4 weeks of TCM formula treatment.
Terms in these criteria, in plain language(4)

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.

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.

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.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Psoralea corylifolia (Buguzhi)-Containing TCM Formula

    Patients with gastrointestinal cancers (esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), hepatocellular carcinoma (HCC), and colorectal cancer (CRC)) who received TCM formulas containing Psoralea corylifolia (Buguzhi) as part of routine clinical care.

    Other: Psoralea corylifolia-Containing TCM Formula

Interventions

  • OtherPsoralea corylifolia-Containing TCM Formula

    Traditional Chinese Medicine herbal formula containing Psoralea corylifolia (Buguzhi), prescribed as part of routine clinical care for gastrointestinal cancers patients.

06

What researchers measure

Primary outcomes

  1. Tumor response evaluation

    Tumor response will be assessed by contrast-enhanced CT or MRI according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Patients will be classified into four categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).

    Time frame: Baseline and at 8-12 weeks after initiation of TCM formula containing Psoralea corylifolia (Buguzhi) treatment

  2. Karnofsky Performance Status (KPS) Score Change

    Changes in Karnofsky Performance Status (KPS) score will be assessed at baseline and after treatment. KPS score ranges from 0 (death) to 100 (normal, no complaints). Improvement is defined as an increase of ≥10 points; deterioration is defined as a decrease of ≥10 points.

    Time frame: Baseline and at 8-12 weeks after initiation of TCM formula containing Psoralea corylifolia (Buguzhi) treatment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Dec 2028, 35 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 12, 2026
StartActual
Jan 1, 2026
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07932951
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Jan 1, 2026
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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