Please assess the completion status of the following clinical trial:

Trial Title: Safety and Efficacy of Intra-Arterial and Intra-Tumoral Ad-p53 With Capecitabine (Xeloda) or Anti-PD-1 in Liver Metastases of Solid Tumors and Recurrent Head and Neck Squamous Cell Cancer

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1/PHASE2
- Number of Arms: 3.0

Eligibility Criteria:
Inclusion Criteria:~1. Signed informed consent~2. Male or female, age 18 or above, who agree to use barrier contraception throughout the study. Females of child-bearing potential must be non-pregnant and non-lactating throughout the study.~3. Histologically or cytologically confirmed solid tumors or hepatocellular carcinoma with known disease progression.~4. Each patient entered on the study must have disease that is evaluable for response using RECIST 1.1 criteria with a minimum size of 1 cm by CT/MRI or physical examination~5. Carcinoma patients in Arm A or Arm B must have received at least 1 prior regimen of standard of care systemic antitumor therapy for their metastatic disease and experienced tumor progression within 3 months after the last prior administration of the therapy or experienced unacceptable toxicity to these treatments.~6. Subjects in Arm A and Arm B should have measurable CT evidence of liver metastases or liver lesions that are not treatable by surgical resection or local ablation in consultation with hepatobiliary specialist.~7. The maximum tumor diameters for each Cohort for both Arm A and Arm B should achieve a dose of approximately 1x1011 viral particles (vp)/cm3 of tumor volume. (see Table 1). Please refer to Table for calculating tumor volume.~8. ECOG Performance Status 0 - 1~9. Either no brain metastases or irradiated stable brain metastases~10. Life expectancy at least 3 months~11. No prior autologous or allogeneic organ or tissue transplantation~12. PT/international normalized ratio (INR) ≤ULN; aPTT ≤ULN.~13. ANC ≥1500 cells/mm3~14. Platelet count ≥100,000 cells/mm3~15. Hemoglobin ≥9.0 g/dL~16. Creatinine \<2.0 mg/dL or creatinine clearance ≥50 mL/min~17. Total bilirubin \<1.5 x ULN~18. AST and ALT \<3.0 x ULN~19. Alkaline phosphatase ≤5 x ULN~20. Negative pregnancy test in women of childbearing potential~21. Fertile patients must use effective contraception~22. No non-approved investigational agents or procedures ≤4 weeks of study entry~23. Patients with PRIMARY HEPATIC CANCER must have an undetectable viral load for Hepatitis B and C.~24. Patients with Primary Hepatic Cancer have not recently been treated with antivirals.~25. Troponin blood level within normal limits.~26. Favorable biomarker profile defined by either wild type p53 gene sequence or less than 20% p53 positive tumor cells by immunohistochemistry~27. Echocardiogram with normal ejection fractions~28. Normal lung oxygen saturation by pulse oximeter, as determined by the Principal Investigator based on patient history and status.~29. Arm C patients must have loco-regional recurrent head and neck squamous cell carcinoma (HNSCC), excluding endolaryngeal recurrence, meeting the following criteria:~    * Tumor progression within 6 months of platinum-based chemotherapy~   * All HNSCC lesions should be in the head and neck region and suitable for intra-tumoral injection~   * The total sum of Ad-p53 Injection Doses (mL) based upon the tumor volumes shown in Table 2 should be less than or equal to 25 mL as the MTD of Ad-p53 is 2.5 x1013 vp/treatment day.~Exclusion Criteria~1. Subjects must not be candidates for hepatic surgery or locoregional therapy of liver tumors with curative intent.~2. Liver tumors must not be estimated to invade approximately more than one-third of the liver.~3. Liver tumor-directed therapy, hepatic surgery, antibody-based therapy, or immunotherapy must not have been performed \< 28 days, chemotherapy \< 21 days, and targeted small molecule therapy or hormonal therapy \< 14 days prior to enrollment. No radiation to tumor sites during the last 4 weeks.~4. No macroscopic intra-vascular invasion by tumors of the main portal vein, hepatic vein or vena cava.~5. Chronic liver dysfunction prior to development of liver metastases (Child-Pugh C or greater).~6. Active alcohol dependence~7. Prior radiation performed to areas of measurable disease ≤ four weeks of study entry unless there is documented evidence of disease progression.~8. Use of systemic anti-cancer therapy ≤ 4 weeks, or six weeks if the systemic therapy contains a nitrosourea or mitomycin C.~9. Neuropathy (≥grade 2 CTCAE)~10. History of allergic reactions to any components of the treatments~11. Prior additional malignancy within 2 years except for non-melanoma skin cancer, carcinoma in situ of the breast, oral cavity or cervix.~12. Severe, active comorbidity, including any of the following:~    1. Active clinically serious infection requiring intravenous antibiotics at the time of study entry (CTCAE Grade 2)~   2. Hepatic insufficiency not due to tumor resulting in clinical jaundice or bilirubin \>1.5 x ULN and/or coagulation defects~   3. Thrombotic or embolic event within the last 6 months including portal vein thrombosis~   4. Must not require concomitant treatment with anticoagulants~   5. QTcb \>470 ms~   6. Bleeding or evidence or history of clinically significant bleeding diathesis or coagulopathy within the last 3 months~   7. Uncontrolled hypertension on anti-hypertensive medication (systolic blood pressure \>150 mmHg or diastolic blood pressure \>95 mmHg)~   8. Must not have been diagnosed with autoimmune disease or be immunosuppressed~   9. Patients with non-hepatocellular carcinoma must not have acute or chronic hepatitis B or hepatitis C infection~   10. Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or immunosuppressive medication including high-dose corticosteroids.~   11. Severe bleeding, hemoptysis, gastrointestinal hemorrhage, CNS bleeding, clinically significant hemorrhage or vaginal bleeding during the last 6 months~   12. Subjects must not have evidence of pneumonitis or inflammatory lung disease on CT scan and x-ray~13. Chronic treatment for more than 6 months with systemic corticosteroids at doses above 10 mg prednisolone or equivalent before study entry~14. Psychological, familial, sociological or geographical or other condition which in the opinion of the investigator would not permit study follow-up or other compliance with the study protocol.~15. Subjects must not have tumors adjacent to vital structures such as carotid arteries.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Ad-p53 with Xeloda 33.3% of patients (Type: EXPERIMENTAL): Up to 12 patients, in 3+3 cohorts, all patients treated with Intra-arterial Ad-P53 once weekly, dosing dependent on DLT and MTD findings, and daily metronomic Xeloda (capecetabine), at a dose of 625 mg/m2 BID continuously.
- Ad-p53 with Keytruda 33.3% of patients (Type: EXPERIMENTAL): Up to 12 patients, in 3+3 cohorts, all patients treated with Intra-arterial Ad-P53 once weekly, dosing dependent on DLT and MTD findings, and infusions of pembrolizumab every 3 weeks.
- Ad-p53 with Opdivo 33.3% of patients (Type: EXPERIMENTAL): Up to 12 patients treated with intra-tumoral Ad-P53 3 times week 1 of each cycle, dose determined by tumor size, in combination with IV nivolumab (Opdivo) 480 mg, every 4 weeks.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy