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The efficacy of intratumoral injection of H101 (recombinant adenovirus type 5) combined with chemotherapy in the treatment of unresectable pancreatic cancer

The efficacy of intratumoral injection of H101 (recombinant adenovirus type 5) combined with chemotherapy in the treatment of unresectable pancreatic cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064129
Enrollment
Unknown
Registered
2022-09-27
Start date
2022-09-28
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

H101 intratumoral injection combined with AG chemotherapy group:H101
H101 intratumoral injection combined with AG chemotherapy group:GEM + Nab-P

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Pancreatic cancer was diagnosed by preoperative imaging and laboratory examination, and was considered as unresectable by imaging evaluation, and the final pathological diagnosis confirmed; 2. The tumor was unresectable and no distant metastasis was found during intraoperative exploration, and the final pathological diagnosis confirmed; 3. Aged 18-75 years; 4. KPS score >= 60 points 5. Life expectancy of more than 2 months; 6. Patients or their legal representatives were willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with non-ductal adenocarcinoma confirmed by biopsy; 2. Patients with severe pancreatic portal hypertension and subsequent injection therapy may be at higher risk of bleeding; 3. Severe, uncontrolled medical disorders that may impair the ability of the subjects to receive the prescribed treatment, including but not limited to HIV positive, active tuberculosis, HBV DNA copy number > 10^3 ml (no more than 10^4 ml); 4. The patient had a history of other malignancies (skin basal-cell carcinoma, excluding cervical carcinoma in situ) within 5 years; 5. Other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy, or traditional Chinese medicine must be used concurrently during the trial for anti-tumor treatment; 6. The patient has used or is using chemotherapy or other antineoplastic drugs in the past; 7. Preoperative ultrasound evaluation showed that the tumor size was small, the tumor location was close to or behind the important blood vessels, and so on, which may lead to the low success rate of intratumoral injection of virus under ultrasound and the high incidence of complications after injection.

Design outcomes

Primary

MeasureTime frame
Safety;

Secondary

MeasureTime frame
disease free survival;overall survival;surgical conversion rate;pain relief;

Countries

China

Contacts

Public ContactChunlu Tan

Department of Pancreatic Surgery, West China Hospital, Sichuan University

chunlutan@163.com18980606406

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026