| CTRI Number |
CTRI/2024/09/074163 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Fecal microbiota transplantation] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess stool transplantation as treatment for advanced, non-operable liver cancer resistant to standard treatments |
|
Scientific Title of Study
|
Role of Fecal microbiota transplantation in treatment-refractory unresectable hepatocellular carcinoma: a pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalimar |
| Designation |
Professor, Department of Gastroenterology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No.127, Ist floor, Human Nutrition Unit, Old OT block All India Institute of Medical Science, Ansari Nagar South Delhi, India-110029
Stadium Road,
South Delhi, India- 110029
South
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalimar |
| Designation |
Professor, Department of Gastroenterology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No.127, Ist floor, Human Nutrition Unit, Old OT block All India Institute of Medical Science, Ansari Nagar South Delhi, India-110029
Stadium Road,
South Delhi, India- 110029
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalimar |
| Designation |
Professor, Department of Gastroenterology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No.127, Ist floor, Human Nutrition Unit, Old OT block All India Institute of Medical Science, Ansari Nagar South Delhi, India-110029
Stadium Road,
South Delhi, India- 110029
DELHI
110029
India |
| Phone |
9868397211 |
| Fax |
|
| Email |
drshalimar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi, India-110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Gastroenterology and Human Nutrition Unit, Room no 3111, 3rd floor teaching block All India Institute of Medical Sciences, New Delhi Sri Aurobindo Marg, Ansari Nagar East, South Delhi, Delhi, India- 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shalimar |
All India Institute of Medical Sciences, New Delhi |
Room No.127, Ist floor, Human Nutrition Unit, Old OT block All India Institute of Medical Science, Ansari Nagar South Delhi, India-110029
South
DELHI |
9868397211
drshalimar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C220||Liver cell carcinoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fecal microbiota transplantation |
Single session of fecal microbiota transplantation (donor being healthy patients) delivered into duodenum via UGI endoscopy, followed later by systemic therapy for 6 months |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than or equal to 18 years
2. Radiologically or histologically confirmed Hepatocellular carcinoma
3. Barcelona Clinic Liver Cancer stage C
4. ECOG performance status 0-2
5. Child pugh class A5-B8
6. Adequate hematological and end-organ function, defined as follows:
a. AST and ALT less than 5 x ULN
b. Serum bilirubin less than 3 mg/dL
c. Serum creatinine less than or equal to 1.5 mg/dL
d. Hemoglobin more than or equal to 8 mg/dL
e. Platelet count more than or equal to 50k/mm3
f. Leukocytes more than or equal to 2500/mm3
7. Written informed consent |
|
| ExclusionCriteria |
| Details |
A. Known fibrolamellar carcinoma or mixed cholangiocellular carcinoma
B. Concomitant other malignancies
C. Uncontrolled ascites
D. Overt hepatic encephalopathy or concomitant treatment with rifaximin
E. Not able to undergo UGI endoscopy
F. Recent antibiotic use within 2 months
G. Prior history of fecal microbiota transplantation
H. Prior allogeneic stem cell or solid organ transplantation
I. Active or history of severe autoimmune disease
J. Severe infection within 4 weeks prior to study inclusion
K. Active infection at the time of enrollment
L. Pregnant or breastfeeding women
M. Treatment with systemic immunosuppressive medication with the following exceptions:
a. Acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for contrast allergy)
b. Mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for adrenal insufficiency
N. Major surgery within 4 weeks prior to study inclusion or minor surgery (excluding placement of a vascular access device) within 3 days prior to study inclusion
O. History of gastrointestinal fistula or perforation, or intra-abdominal abscess within 6 months prior to study inclusion
P. Serious, non-healing wound or active ulcer
Q. Any clinical or laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of addition of fecal microbiota transplantation to systemic therapy in terms of best overall response, objective response rate (ORR), disease control rate (DCR) evaluated according to mRECIST criteria, in comparison to historical controls |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of addition of fecal microbiota transplantation to systemic therapy, as assessed by objective response rate (ORR) and disease control rate (DCR) |
6 months |
| Efficacy of addition of fecal microbiota transplantation to systemic therapy, as assessed by progression-free survival (PFS) and overall survival (OS). |
12 months |
| Safety of addition of fecal microbiota transplantation to systemic therapy, measured by incidence and severity of treatment-related adverse events, determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 |
6 months |
| Effect of addition of fecal microbiota transplantation to systemic therapy, on recipient gut microbiota composition, diversity (alpha and beta), rate of change from baseline and similarity to donor stool composition over time |
2 months |
| Differences in circulating immune cells and microbial metabolites in patients before and after fecal microbiota transplantation. |
2 months |
| Quality of life as reported by EORTC QLQ-C30 and QLQ-HCC18 |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drshalimar@gmail.com ].
- For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, accounting for approximately 75-85% of cases worldwide. A substantial proportion of patients don’t show response with around 25-50% patients having disease progression on existing treatment modalities (immunotherapy and targeted therapies) in unresectable hepatocellular carcinoma. Fecal microbiota transplantation has been shown to be safe and effective in other malignancies like malignant melanoma. It plays a complementary role in modulating tumor microenvironment and increases response rates to immunotherapy in these patients. Therefore, we plan to explore the role of fecal microbiota transplantation in increasing the efficacy of existing therapies in unresectable hepatocellular carcinoma. |